list of substances under psur ws scheme and …bah-psur.com/dokumente/list of substances under psur...

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A B C D E F G H I J K L

Active substance name (INN)

Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year

and month)Firm's Name Comments

Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?

Substances under PSUR

Work Sharing scheme

or Others (contained in

Nationally Authorised

Products including

MRP/DCP)

sulbactam

19871116 201311 Pfizer AT/H/PSUR/0004/003 201402

No, except if

required nationally

by a competent

authority

Work Sharing

idarubicin

19891129 201311 Pfizer AT/H/PSUR/0005/003 201402

No, except if

required nationally

by a competent

authority

Work Sharing

dexibuprofen

20000725 31/08/2014 Gebro Pharma AT/H/PSUR/0009/003 29/11/2014

No, except if

required nationally

by a competent

authority

Work Sharing

nicorandil

19900209 201302 Merck AT/H/PSUR/0023/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

azelastine

20/11/1990 201309 Meda

Request from MEDA Pharma

GmbH & Co.KG to amend

the DLP to 31/12/2014.

Request agreed by the P-

RMS AT. The substance has

been moved to the EURD

list as detailed in the cover

note "Assessment of

Periodic Safety Update

Reports for National

Authorised" Product

AT/H/PSUR/0038/001 201312

No, except if

required nationally

by a competent

authority

Work Sharing

biperiden

19550816 201308 Abbott AT/H/PSUR/0039/001 201311

No, except if

required nationally

by a competent

authority

Work Sharing

calcium carbonate,

colecalciferol 01/01/1960 201310 Nycomed AT/H/PSUR/0040/001 201401

No, except if

required nationally

by a competent

authority

Work Sharing

human coagulation factor IX

12/07/1985 201307 Baxter

The PSURs submitted for

products containing

human coagulation factor

IX and authorised

nationally will be

assessed under a single

assessment procedure

with the centrally

authorised product

Nonafact. For more

details, please refer to

the EURD list:

http://www.emea.europa

.eu/ema/index.jsp?curl=p

ages/regulation/documen

t_listing/document_listing

_000361.jsp&mid=WC0b

01ac058066f910

AT/H/PSUR/0041/001 201310

No, except if

required nationally

by a competent

authority

Work Sharing

human coagulation factor VII

01/11/1975 201310 Baxter AT/H/PSUR/0042/001 201401

No, except if

required nationally

by a competent

authority

Work Sharing

List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised

Status July 2013 - In brown font: changes made since last publication on 30th June 2013

PSUR Work Sharing list - July 2013

2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

human coagulation factor

VIII (inhibitor bypassing

fraction)04/02/1977 31/01/2014 AT/H/PSUR/0043/001 01/05/2014

No, except if

required nationally

by a competent

authority

Work Sharing

domperidone / domperidone

maleate, cinnarizine

19780300 201301 J&J

The previous entry

"domperidone maleate,

cinnarizine " with

procedure number

BE/H/PSUR/0020/00X

has been merged with

the entry "domperidone "

standalone

BE/H/PSUR/0005/003 yearly PSURs 201401 201304 Yes Work Sharing

vecuronium bromide 19901101 201311 Organon CZ/H/PSUR/0002/003 201402 Yes Work Sharinglevobunolol 19890608 01/06/2014 Allergan CZ/H/PSUR/0006/003 30/08/2014 Yes Work Sharingtirofiban

20030514 201305 IROKO DE/H/PSUR/0001/002 201308

No, except if

required nationally

by a competent

authority

Work Sharing

ezetimibe + simvastatin Inegy 20040402 201403 MSD DE/H/PSUR/0020/002 201406 Yes Work Sharingmefloquine 19850517 30/04/2013 Roche DE/H/PSUR/0022/003 19/02/2014 29/07/2013 Yes Work Sharingmoxifloxacin (systemic use)

19990531 201305 Bayer Schering DE/H/PSUR/0023/004 2 yearly PSURs 201308 Yes Work Sharing

dienogest + ethinylestradiol

Valette 19950214 201303 Bayer Schering

Omitted from the

publication on

27/03/2013

DE/H/PSUR/0030/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

gabapentin

19930205 201302 PfizerSubstance omitted in

publication of March 2013DE/H/PSUR/0035/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

modafinil

19940901 201308 Cephalon DE/H/PSUR/0044/003 yearly PSURs 201311

No, except if

required nationally

by a competent

authority

Work Sharing

ciprofloxacin hydrochloride,

dexamethasone acetate (ear

drops, suspension)31/05/2012 30/04/2013

Alcon Pharma

GmbH

DE volunteered to act as

P-RMSDE/H/PSUR/0047/001 29/07/2013

No, except if

required nationally

by a competent

authority

Work Sharing

atorvastatin (paediatric

indication) 07/11/1996 31/10/2013 PfizerDE accepts to act as P-

RMSDE/H/PSUR/0048/001 yearly PSURs 29/01/2014

No, except if

required nationally

by a competent

authority

Other

dorzolamide + timolol

Cosopt 19980306 201302 MSD DK/H/PSUR/0001/003 201305

No, except if

required nationally

by a competent

authority

Work Sharing

oxcarbazepine 19990810 201308 Novartis DK/H/PSUR/0002/003 201311 Yes Work Sharingbicalutamide 19950228 201402 AstraZeneca DK/H/PSUR/0006/003 201405 Yes Work Sharingfluconazole

19880303 201403 Pfizer DK/H/PSUR/0008/003 201406

No, except if

required nationally

by a competent

authority

Work Sharing

pimecrolimus 20011214 201303 Novartis DK/H/PSUR/0009/006 yearly PSURs 201403 201306 Yes Work Sharingtechnetium (99mTc) bicisate

19831008 201310 LANTHEUS MI DK/H/PSUR/0012/003 201401

No, except if

required nationally

by a competent

authority

Work Sharing

misoprostol 19840628 30/06/2014 Pfizer DK/H/PSUR/0014/003 28/09/2014 Yes Work Sharingepirubicin 19820628 30/06/2014 Pfizer DK/H/PSUR/0016/003 28/09/2014 Yes Work Sharingacitretin 19871201 201310 Actavis DK/H/PSUR/0024/003 yearly PSURs 201401 Yes Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

34

35

36

37

38

39

40

41

42

43

44

45

46

47

etoposide

19760217 201302 BMS DK/H/PSUR/0029/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

gadoteridol 19921029 201302 Bracco DK/H/PSUR/0030/002 201305 Yes Work Sharingbudesonide

19920430 201304AstraZeneca /

Dr. Falk PharmaDK/H/PSUR/0041/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

ebastine 19960101 201305 Almirall DK/H/PSUR/0043/002 201308 Yes Work Sharingferumoxsil (siloxane coated

superparamagnetic

ironoxide)19930122 201305 Guerbet DK/H/PSUR/0044/002 201308

No, except if

required nationally

by a competent

authority

Work Sharing

technetium(99m

Tc) macrosalb

19900302 201302 Ge Healthcare DK/H/PSUR/0048/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

ethinylestradiol +

levonorgestrel

Nordette, Stediril,

Follimin, Trinordiol,

Nordiol, Ovran 21,

Neogestrenol,

Stediril-d, Lorette,

Lowette, Alesse,

Loette, Gravistat

125, Microgynon,

Monostep,

Minisiston,

Triquilar, Miranova,

Neogynon

19650422 /

19760427 /

19650422 /

19970327

201304Pfizer / Bayer

ScheringDK/H/PSUR/0054/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

sodium iodide [123

I]

19950131 201303 Ge Healthcare DK/H/PSUR/0056/001 201306

No, except if

required nationally

by a competent

authority

Work Sharing

mepivacaine

19560401 201303 AstraZeneca DK/H/PSUR/0057/001 201306

No, except if

required nationally

by a competent

authority

Work Sharing

mepivacaine + adrenalineCarbocaine-

Adrenaline19560401 201303 Astrazeneca DK/H/PSUR/0058/001 201306

No, except if

required nationally

by a competent

authority

Work Sharing

ethinylestradiol + gestodene

Minesse,

Harmonet, Tri-

minulet, Minulet,

Mirelle, Meliane,

Femovan, Milvane

19990614 /

19950317 /

19980127 /

19860709

201403Pfizer / Bayer

Schering

Combination transferred

from FR to DK

Awaiting outcome of the

on-going EU referral

procedure to know

whether the DLP needs to

be modified.

DK/H/PSUR/0060/001 201406

No, except if

required nationally

by a competent

authority

Work Sharing

nortriptyline

19630331 201303 Lundbeck EE/H/PSUR/0010/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

cinitapride

19930311 201306 Almirall ES/H/PSUR/0001/002 201309

No, except if

required nationally

by a competent

authority

Work Sharing

lovastatin

19870721 201307 MSD ES/H/PSUR/0002/002 201310

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

48

49

50

51

52

53

54

55

56

57

58

59

60

61

hydroquinidine

19940311 201403 Sanofi Aventis ES/H/PSUR/0004/002 201406

No, except if

required nationally

by a competent

authority

Work Sharing

clebopride

19790222 30/06/2014 Almirall ES/H/PSUR/0005/003 28/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

almotriptan

19991223 30/06/2014 Almirall ES/H/PSUR/0008/003 28/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

rupatadine

20051212 201306 J. Uriach y Cia

PSUR frequency changed

to 6-month in Feb2012,

when pediatric oral

solution was authorised.

ES/H/PSUR/0009/005 6 months 201312 201309

No, except if

required nationally

by a competent

authority

Work Sharing

paricalcitol

19980417 201308 Abbott ES/H/PSUR/0016/003 201311

No, except if

required nationally

by a competent

authority

Work Sharing

bemiparin

19980416 201304

Laboratorios

farmacéuticos

ROVI, S.A.

ES/H/PSUR/0020/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

gasiloxe

10/11/2011 26/07/2013Venter Pharma

S.L.

New active substance

added with ES as P-RMSES/H/PSUR/0022/001 6 months 26/01/2014 04/10/2013

No, except if

required nationally

by a competent

authority

Work Sharing

azithromycin

19910404 201404 Pfizer FI/H/PSUR/0007/003 29/07/2014

No, except if

required nationally

by a competent

authority

Work Sharing

meloxicam

19950508 201307Boehringer

IngelheimFR/H/PSUR/0001/002 201310

No, except if

required nationally

by a competent

authority

Work Sharing

tixocortol / chlorhexidine

gluconate, tixocortol pivalate

19761118 201311 Pfizer

As agreed by FR,

products containing the

combinations

"chlorhexidine gluconate,

tixocortol pivalate " will

be assesssed together

with "tixocortol

standalone ". The

combination has

therefore been removed

from the EURD list.

FR/H/PSUR/0004/002 201402

No, except if

required nationally

by a competent

authority

Work Sharing

pravastatin

19890331 201403 BMS FR/H/PSUR/0007/003 201406

No, except if

required nationally

by a competent

authority

Work Sharing

irinotecan

19950505 04/05/2014 Pfizer FR/H/PSUR/0009/003 02/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing

ropinirole 19960708 201307 GSK FR/H/PSUR/0010/002 201310 Yes Work Sharingpravastatin + acetylsalicylic

acid Selktine Plus ASA 19890331 201403 BMS FR/H/PSUR/0011/004 201406

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

buprenorphine19820330 31/07/2014

Reckitt &

BenckiserFR/H/PSUR/0012/003 29/10/2014 Yes Work Sharing

ferumoxtran-10

(superparamagnetic

ironoxide)19940823 31/08/2014 Guerbet FR/H/PSUR/0013/003 29/11/2014

No, except if

required nationally

by a competent

authority

Work Sharing

alprazolam 19800312 201303 Pfizer FR/H/PSUR/0036/002 201306 Yes Work Sharingivermectin

20041119 201304 MSD FR/H/PSUR/0037/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

sulproston

19801217 201304 Bayer Schering FR/H/PSUR/0038/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

benazepril +

hydrochlorothiazide Cibadrex 19920519 201305 Novartis FR/H/PSUR/0043/002 201308

No, except if

required nationally

by a competent

authority

Work Sharing

pefloxacin

19840807 31/08/2014 Sanofi Aventis FR/H/PSUR/0049/003 29/11/2014

No, except if

required nationally

by a competent

authority

Work Sharing

captopril +

hyrochlorothiazide Captea 19800415 201304BMS / Sanofi

AventisFR/H/PSUR/0050/002 201307

No, except if

required nationally

by a competent

authority

Work Sharing

fosfomycin (IV formulation)

19830713 201307 Sanofi Aventis FR/H/PSUR/0061/002 201310

No, except if

required nationally

by a competent

authority

Work Sharing

macrogol 4000

19950505 201305 Ipsen FR/H/PSUR/0062/002 201308

No, except if

required nationally

by a competent

authority

Work Sharing

macrogol 4000 and

combinations Fortrans 19950505 201305 Ipsen FR/H/PSUR/0063/001 201308

No, except if

required nationally

by a competent

authority

Work Sharing

fosfomycin (oral formulation)

19860827 201307 Zambon FR/H/PSUR/0064/002 201310

No, except if

required nationally

by a competent

authority

Work Sharing

chlorpromazine

19520529 31/05/2014 Sanofi Aventis FR/H/PSUR/0065/002 29/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing

bromazepam 19730901 31/08/2014 Roche FR/H/PSUR/0066/002 29/11/2014 Yes Work Sharingparacetamol (IV formulation)

201301 BMS FR/H/PSUR/0072/001 yearly PSURs 07/05/2014 201304 Yes Work Sharing

hydrotalcite

19920301 201303 Bayer Schering HU/H/PSUR/0022/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

aceclofenac 19900319 201403 Almirall HU/H/PSUR/0030/002 201406 Yes Work Sharingdanaparoid

19921201 201311 Organon IE/H/PSUR/0004/003 201402

No, except if

required nationally

by a competent

authority

Work Sharing

simvastatin

19880406 05/04/2014 MSD IE/H/PSUR/0009/003 04/07/2014

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

octreotide

19950623 30/06/2014 Novartis IE/H/PSUR/0010/003 28/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

acamprosate

19870724 01/07/2014 Merck KGaA IE/H/PSUR/0011/003 29/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

flurbiprofen

19761110 201311 Abbott IT/H/PSUR/0001/003 201402

No, except if

required nationally

by a competent

authority

Work Sharing

bacillus clausii multi-

antibioresistant spores 19781103 201311 Sanofi Aventis IT/H/PSUR/0002/003 201402

No, except if

required nationally

by a competent

authority

Work Sharing

indobufen

19840505 04/05/2014 Pfizer IT/H/PSUR/0004/003 02/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing

ioxaglic acid

19790800 201302 GuerbetSubstance omitted in

publication of March 2013IT/H/PSUR/0020/003 201305

No, except if

required nationally

by a competent

authority

Work Sharing

nicardipine

19810531 201305 Astellas IT/H/PSUR/0021/002 201308

No, except if

required nationally

by a competent

authority

Work Sharing

folinic acid / (di)sodium

folinate / calcium folinate 19820304 31/08/2014 Bracco IT/H/PSUR/0024/002 29/11/2014

No, except if

required nationally

by a competent

authority

Work Sharing

chlorprothixene

19590331 201303 Lundbeck LV/H/PSUR/0003/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

piribedil

19901001 201403 Servier LV/H/PSUR/0004/002 201406

No, except if

required nationally

by a competent

authority

Work Sharing

benzylnicotine + camphora +

dimethyl sulphate +

turpentine oilCapsicam 19940101 201303 JSC Grindeks LV/H/PSUR/0008/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

dienogest + estradiol

Climodien 20001213 201306 Bayer Schering NL/H/PSUR/0001/003 201309

No, except if

required nationally

by a competent

authority

Work Sharing

rizatriptan

19980211 201306 MSD NL/H/PSUR/0002/002 201309

No, except if

required nationally

by a competent

authority

Work Sharing

mirtazapine

19940901 201309 Organon NL/H/PSUR/0006/003 201312

No, except if

required nationally

by a competent

authority

Work Sharing

amsacrine

19820423 01/06/2014 NordMedica NL/H/PSUR/0011/002 30/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

96

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

solifenacin

20040608 08/06/2014 Astellas NL/H/PSUR/0012/002 06/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

quetiapine

19970731 31/07/2014 AstraZeneca NL/H/PSUR/0021/005 29/10/2014

No, except if

required nationally

by a competent

authority

Work Sharing

trandolapril

19920219 201402 Abbott NL/H/PSUR/0027/002 201405

No, except if

required nationally

by a competent

authority

Work Sharing

ribavirin (i.v. application) 20020409 201307 Roche NL/H/PSUR/0036/005 yearly PSURs 201310 Yes Work Sharingdrospirenone,

ethinylestradiol 07/03/2000 06/09/2013 Bayer Schering NL/H/PSUR/0037/003 05/12/2013

No, except if

required nationally

by a competent

authority

Other

fenoterol + ipratropium

Berodual 201302Boehringer

IngelheimNL/H/PSUR/0046/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

trandolapril + verapamil

Tarka 19950316 201303 AbbottCombination omitted in

publication of March 2013NL/H/PSUR/0047/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

losartan +

hydrochlorothiazide

Hyzaar, Cozaar

Plus, Fortzaar 19950215 201302 MSD NL/H/PSUR/0057/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

sertraline

19900301 201403 Pfizer

The P-RMSship was

transferred from SK to

NL, as NL is the

rapporteur for the

innovator product Zoloft®

NL/H/PSUR/0059/002 201406

No, except if

required nationally

by a competent

authority

Work Sharing

cilastatin + imipenem

Tienam 19840628 27/06/2014 MSD NO/H/PSUR/0003/002 25/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

labetalol

19770304 201302GSK

Aspen PharmaNO/H/PSUR/0011/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

nafarelin

19900215 201302 Pfizer NO/H/PSUR/0012/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

brotizolam

19830515 201312Boehringer

IngelheimPT/H/PSUR/0001/003 201403

No, except if

required nationally

by a competent

authority

Work Sharing

tioconazole

19810413 01/04/2014 Pfizer PT/H/PSUR/0003/003 30/06/2014

No, except if

required nationally

by a competent

authority

Work Sharing

buflomedil

19790523 201405 Amdipharm PT/H/PSUR/0004/003 201408

No, except if

required nationally

by a competent

authority

Work Sharing

oxatomide

201301 J&J PT/H/PSUR/0005/005 yearly PSURs 201401 201304

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

112

113

114

115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

desogestrel

19980701 201307 Organon SE/H/PSUR/0001/003 201310

No, except if

required nationally

by a competent

authority

Work Sharing

finasteride 19980417 201308 MSD SE/H/PSUR/0002/007 yearly PSURs 201311 Yes Work Sharingtolterodine

19970905 201309 Pfizer SE/H/PSUR/0003/003 201312

No, except if

required nationally

by a competent

authority

Work Sharing

levosimendan

20000922 201309 Orion SE/H/PSUR/0004/003 201312

No, except if

required nationally

by a competent

authority

Work Sharing

tibolone

19871201 201312 Organon SE/H/PSUR/0006/003 201403

No, except if

required nationally

by a competent

authority

Work Sharing

formoterol

19900629 31/05/2014 AstraZeneca SE/H/PSUR/0009/003 29/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing

latanoprost + timolol

Xalcom 19960605 04/06/2014 PfizerMissing from the previous

publicaion on 27.03.13SE/H/PSUR/0010/003 02/09/2014

No, except if

required nationally

by a competent

authority

Work Sharing

budesonide + formoterol

Symbicort 20000825 201308 AstraZeneca SE/H/PSUR/0012/004 201311

No, except if

required nationally

by a competent

authority

Work Sharing

valsartan

19960513 201304 Novartis SE/H/PSUR/0024/004 201307

No, except if

required nationally

by a competent

authority

Work Sharing

enalapril

20041101 201303 MSD SE/H/PSUR/0037/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

felodipine + ramipril

Unimax, Tazko 19890110 201303AstraZeneca /

Sanofi AventisSE/H/PSUR/0038/002 201306

No, except if

required nationally

by a competent

authority

Work Sharing

ketoprofen (topical use only)19850910 201309

Sanofi Aventis /

Bayer ScheringSE/H/PSUR/0049/003 yearly PSURs 201312 Yes Work Sharing

dinoprostone

26/09/1972 30/09/2013 PfizerSE accepts to act as P-

RMSSE/H/PSUR/0051/001 29/12/2013

No, except if

required nationally

by a competent

authority

Work Sharing

doxylamine07/04/1948 28/08/2013 Bayer

SE volunteered to act as

P-RMS.SE/H/PSUR/0052/001 6 months 28/02/2014 06/11/2013 Yes Work Sharing

carteolol

19840307 201403Laboratoire

Théa SK/H/PSUR/0002/003 201406

No, except if

required nationally

by a competent

authority

Work Sharing

lomustine 19760126 201306 BMS SK/H/PSUR/0007/002 201309 Yes Work Sharingsertindole

20020711 201307 Lundbeck UK/H/PSUR/0004/003 6-monthly PSURs 201401 201310

No, except if

required nationally

by a competent

authority

Work Sharing

piroxicam

19790403 01/04/2014 Pfizer UK/H/PSUR/0009/003 30/06/2014

No, except if

required nationally

by a competent

authority

Work Sharing


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

130

131

132

133

134

135

136

137

138

139

140

141

142

143

144

lanreotide

19940516 16/05/2014 Ipsen UK/H/PSUR/0010/003 14/08/2014

No, except if

required nationally

by a competent

authority

Work Sharing

lercanidipine

19960322 31/08/2014 Recordati UK/H/PSUR/0011/002 29/11/2014

No, except if

required nationally

by a competent

authority

Work Sharing

etoricoxib

20020213 201303 MSD UK/H/PSUR/0032/005 yearly PSURs 201306

No, except if

required nationally

by a competent

authority

Work Sharing

artemether + lumefantrin

Riamet, Coartem 19981014 201310 Novartis UK/H/PSUR/0049/002 201401

No, except if

required nationally

by a competent

authority

Work Sharing

mesalazine

Salofalk 19840220 201302 Dr. Falk Pharma UK/H/PSUR/0052/002 201305

No, except if

required nationally

by a competent

authority

Work Sharing

latanoprost (products with

paediatric indication)

19960605 201310 Pfizer

Re-start of the PSUR

cycle with 6 monthly

submissions following the

extension of the

indication for children

(Article 29 paediatric).

UK/H/PSUR/0064/006 6-monthly PSURs 201401

No, except if

required nationally

by a competent

authority

Work Sharing

methylphenidate

19541006 201310 Novartis UK/H/PSUR/0068/005 Yearly PSURs 201401

No, except if

required nationally

by a competent

authority

Work Sharing

lubiprostone

31/01/2006 31/07/2013

Sucampo

Pharma Europe,

Ltd

UK volunteered to act as

P-RMSUK/H/PSUR/0077/001 6-monthly PSURs 31/01/2014 09/10/2013

No, except if

required nationally

by a competent

authority

Work Sharing

acetylsalicylic Acid, bisoprolol

05/11/2010 05/11/2013ASA Pharma

PLC



No, except if

required nationally

by a competent

authority

Work Sharing

clevidipine

23/11/2011 23/05/2013

The Medicines

Company UK

Ltd



No, except if

required nationally

by a competent

authority

Work Sharing

lisdexamfetamine

01/02/2013 31/07/2013

Shire

Pharmaceutical

Contracts Ltd.



No, except if

required nationally

by a competent

authority

Work Sharing

acetylsalicylic acid

19570105 201302 201305

No, except if

required nationally

by a competent

authority

Other

acetylsalicylic acid

combinations201302

Deletion of the entries

"Substance +

combinations" as it

causes confusion for

stakeholders

201305

No, except if

required nationally

by a competent

authority

Other

acetylsalicylic acid,

esomeprazole 12/08/2011 29/08/2013 27/11/2013

No, except if

required nationally

by a competent

authority

Other

aciclovir, hydrocortisone

31/07/2009 31/07/2013 29/10/2013

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

145

146

147

148

149

150

151

152

153

154

155

156

157

158

159

adapalene, benzoyl peroxide

30/09/2007 30/09/2013 29/12/2013

No, except if

required nationally

by a competent

authority

Other

ajmaline

22/02/1990 22/08/2013 20/11/2013

No, except if

required nationally

by a competent

authority

Other

algeldrate

201301

Substance moved to the

EURD list with DLP

09/11/2025 and 13 years

frequency; without

request for generics

PSUR.

201304 Yes Other

allergen products for

treatment: grass and cereal

pollen, single or mixes (oral

preparations, solid forms)

native

20/10/2006 24/06/2013 22/09/2013

No, except if

required nationally

by a competent

authority

Other

almitrine

10/12/1982 30/04/2013 29/07/2013

No, except if

required nationally

by a competent

authority

Other

alverine

19500210 201302 201305

No, except if

required nationally

by a competent

authority

Other

alverine + simeticone

19900605 201302 201305

No, except if

required nationally

by a competent

authority

Other

ambroxol, clenbuterol

27/06/1984 17/09/2013 16/12/2013

No, except if

required nationally

by a competent

authority

Other

amifostine

Not Available* 01/03/2014 30/05/2014

No, except if

required nationally

by a competent

authority

Other

aminohippurate

19630224 201302 201305

No, except if

required nationally

by a competent

authority

Other

aminosalicylate sodium

Not Available* 05/10/2013 03/01/2014

No, except if

required nationally

by a competent

authority

Other

amitriptyline hydrochloride,

chlordiazepoxide Not Available* 31/01/2014 01/05/2014

No, except if

required nationally

by a competent

authority

Other

ampicillin

19620301 201303 201306

No, except if

required nationally

by a competent

authority

Other

ampicillin + cloxacillin

201303 201306

No, except if

required nationally

by a competent

authority

Other

apomorphine

28/05/2001 28/05/2013 26/08/2013

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

160

161

162

163

164

165

166

167

168

169

170

171

172

173

174

aprotinin, human coagulation

factor viii, human fibrinogen Not Available* 01/12/2013 01/03/2014

No, except if

required nationally

by a competent

authority

Other

artemether, lumefantrin

(dispersible tablet) 25/04/2012 24/04/2013 23/07/2013

No, except if

required nationally

by a competent

authority

Other

atenolol

19760219 201302 201305

No, except if

required nationally

by a competent

authority

Other

atenolol + indapamide

201302 201305

No, except if

required nationally

by a competent

authority

Other

atomoxetine

26/11/2002 26/11/2013 24/02/2014

No, except if

required nationally

by a competent

authority

Other

aureomycine

19920818 201303 201306

No, except if

required nationally

by a competent

authority

Other

azoximer bromide

22/10/2002 31/08/2014 29/11/2014

No, except if

required nationally

by a competent

authority

Other

beclometasone dipropionate,

formoterol fumarate Not Available* 14/07/2013 12/10/2013

No, except if

required nationally

by a competent

authority

Other

beclometasone dipropionate,

salbutamol micronized Not Available* 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other

bendamustine hydrochloride

07/07/2010 06/07/2013 04/10/2013

No, except if

required nationally

by a competent

authority

Other

benzatropine

201303 201306

No, except if

required nationally

by a competent

authority

Other

benzylbenzoate

201302 201305

No, except if

required nationally

by a competent

authority

Other

bilastine

08/09/2010 07/03/2014 05/06/2014

No, except if

required nationally

by a competent

authority

Other

biperiden

16/08/1955 15/08/2013 13/11/2013

No, except if

required nationally

by a competent

authority

Other

bovine aprotinin, human

coagulation factor xiii, human

fibrinogen, human

fibronectin, plasminogen

11/08/1998 10/08/2013 08/11/2013

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

175

176

177

178

179

180

181

182

183

184

185

186

187

188

189

190

191

brompheniramine

08/08/1959 31/08/2014 29/11/2014

No, except if

required nationally

by a competent

authority

Other

bupivacaine

27/04/1966 26/04/2014 25/07/2014

No, except if

required nationally

by a competent

authority

Other

bupivacaine hydrochloride,

epinephrine 27/04/1966 26/04/2014 25/07/2014

No, except if

required nationally

by a competent

authority

Other

caffeine

19690414 201302 201305

No, except if

required nationally

by a competent

authority

Other

calcium carbonate,

colecalciferol 15/07/1981 31/10/2013 29/01/2014

No, except if

required nationally

by a competent

authority

Other

calcium levofolinate

19910309 201303 201306

No, except if

required nationally

by a competent

authority

Other

carbidopa monohydrate Not Available* 31/10/2013 29/01/2014 Yes Othercarbidopa, levodopa 13/08/1973 01/10/2013 30/12/2013 Yes Othercarbolevure

19690331 201302 201305

No, except if

required nationally

by a competent

authority

Other

ce (conjugated estrogens),

mpa (medroxyprogesterone

acetate)01/08/1987 31/08/2014 29/11/2014

No, except if

required nationally

by a competent

authority

Other

cefoxitin

19770316 201303 201306

No, except if

required nationally

by a competent

authority

Other

cetalkonium + choline

salicylate 19950424 201303 201306

No, except if

required nationally

by a competent

authority

Other

chloramphenicol +

aminoacids + Vitamin A 201303 201306

No, except if

required nationally

by a competent

authority

Other

chlornitrofenol

201302 201305

No, except if

required nationally

by a competent

authority

Other

chloroquine phosphate,

proguanil hydrochloride Not Available* 15/11/2013 13/02/2014

No, except if

required nationally

by a competent

authority

Other

chlortalidone + reserpine

19620206 201302 201305

No, except if

required nationally

by a competent

authority

Other

choline salicylate

19631210 201303 201306

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

192

193

194

195

196

197

198

199

200

201

202

203

204

205

206

cisapride

201303 201306

No, except if

required nationally

by a competent

authority

Other

clenbuterol

12/12/1980 17/09/2013 16/12/2013

No, except if

required nationally

by a competent

authority

Other

clobazam

19700206 201302 201305

No, except if

required nationally

by a competent

authority

Other

clobetasol

19730221 201302 201305

No, except if

required nationally

by a competent

authority

Other

clonixin

19750228 201302 201305

No, except if

required nationally

by a competent

authority

Other

codeine + ibuprofen

19930305 201303 201306

No, except if

required nationally

by a competent

authority

Other

colchicine 30/07/1947 30/07/2013 28/10/2013 Yes Othercolistimethate sodium

08/10/1962 31/12/2013 31/03/2014

No, except if

required nationally

by a competent

authority

Other

collagenase clostridium

histolyticum (all indications

except for treatment of

Dupuytren’s contracture in

adult patients with a palpable

cord)

12/12/1969 31/12/2013 31/03/2014

No, except if

required nationally

by a competent

authority

Other

cyproterone, ethinylestradiol

31/05/2014

Outcome of EU referral

Article 107i on Diane: 1

year PSUR cycle with

next DLP on 31/05/2014.

yearly PSURs 29/08/2014

No, except if

required nationally

by a competent

authority

Other

dacarbazine

19780201 201302 201305

No, except if

required nationally

by a competent

authority

Other

dapoxetine

17/12/2008 17/12/2013 17/03/2014

No, except if

required nationally

by a competent

authority

Other

dextromethorphan

hydrobromide, salbutamol

sulfateNot Available* 31/01/2014 01/05/2014

No, except if

required nationally

by a competent

authority

Other

dienogest

02/12/2009 02/12/2013 02/03/2014

No, except if

required nationally

by a competent

authority

Other

dihydroergotamine +

etilefrine 19820319 201303 201306

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

207

208

209

210

211

212

213

214

215

216

217

218

219

220

221

dihydrotachysterol

19590401 201303 201306

No, except if

required nationally

by a competent

authority

Other

diphtheria vaccine (adsorbed)

14/11/1979 01/04/2013 30/06/2013

No, except if

required nationally

by a competent

authority

Other

dutasteride, tamsulosin

hydrochloride 20/11/2001 19/05/2013HU kindly volunteered to

act as P-RMSHU/H/PSUR/0033/001 17/08/2013

No, except if

required nationally

by a competent

authority

Work Sharing

ebastine, pseudoephedrine

Not Available* 31/05/2013 29/08/2013

No, except if

required nationally

by a competent

authority

Other

ethinylestradiol + lynestrenol

19730330 201303 201306

No, except if

required nationally

by a competent

authority

Other

F(ab’)2 fragments of equine

antirabies immunoglobulin 22/05/2000 21/05/2013 19/08/2013

No, except if

required nationally

by a competent

authority

Other

felbamate

19940515 201309 Merck & Co.

Innovator product

withdrawn from FR (last

procedure number was

FR/H/PSUR/0002/001).

Need for new P-RMS

201312 Yes Work Sharing

fenofibrate 04/11/1974 31/07/2014 29/10/2014 Yes Otherfenoterol

201302 201305

No, except if

required nationally

by a competent

authority

Other

fenspiride 08/12/1993 08/04/2014 07/07/2014 Yes Otherferumoxides

Not Available* 30/08/2014 28/11/2014

No, except if

required nationally

by a competent

authority

Other

flunitrazepam

20000101 201310Roche

CHEPLAPHARM

Innovator product

withdrawn from IE (last

procedure number was

IE/H/PSUR/0039/001).

Need for new P-RMS

The MAH stated that the

product is still available in

DE, AT, GR and IT.

201401

No, except if

required nationally

by a competent

authority

Work Sharing

fluorescein (systemic use)

30/11/1971 30/04/2014 29/07/2014

No, except if

required nationally

by a competent

authority

Other

fluorodopa

Not Available* 10/03/2014 08/06/2014

No, except if

required nationally

by a competent

authority

Other

furosemide, spironolactone

11/01/1961 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

222

223

224

225

226

227

228

229

230

231

232

233

234

fusidic acid

22797 30/05/2013HU kindly volunteered to

act as P-RMSHU/H/PSUR/0032/001 28/08/2013

No, except if

required nationally

by a competent

authority

Work Sharing

ganciclovir

15/06/1988 14/06/2013 12/09/2013

No, except if

required nationally

by a competent

authority

Other

glucose, potassium chloride

Not Available* 17/04/2014 16/07/2014

No, except if

required nationally

by a competent

authority

Other

guaifenesin, salbutamol

sulfate Not Available* 31/01/2014 01/05/2014

No, except if

required nationally

by a competent

authority

Other

haemophilus type b and

meningococcal group c

conjugate vaccine19/12/2005 01/02/2014 02/05/2014

No, except if

required nationally

by a competent

authority

Other

haemophilus type b

conjugate vaccines 06/02/1992 06/02/2014 07/05/2014

No, except if

required nationally

by a competent

authority

Other

hepatitis a (inactivated),

typhoid polysaccharide

vaccine (adsorbed).22/06/1999 22/06/2014 20/09/2014

No, except if

required nationally

by a competent

authority

Other

hepatitis A vaccine

(inactivated, virosome) 14/12/1999 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other

hepatitis A vaccines

(inactivated, adsorbed) 01/01/1992 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other

human hemin

05/05/1995 31/05/2013 29/08/2013

No, except if

required nationally

by a competent

authority

Other

human plasma (pooled and

treated for virus inactivation) 31/05/2006 28/02/2014 29/05/2014

No, except if

required nationally

by a competent

authority

Other

human plasma protease C1

inhibitor 23/07/1979 04/08/2013 02/11/2013

No, except if

required nationally

by a competent

authorityhydralazine

19520313 201303 201306

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

235

236

237

238

239

240

241

242

243

244

245

hydrocortisone /

hydrocortisone (indicated in

adrenal insufficiency except

the modified release tablets

formulation)

05/08/1952 31/08/2014

This entry has been

renamed

"Hydrocortisone /

Hydrocortisone

(indicated in adrenal

insufficiency except

the modified release

tablets formulation ” in

order to avoid confusion

with the CAP included in

the EURD list and to

harmonise the DLP of the

products concerned.

29/11/2014

No, except if

required nationally

by a competent

authority

Other

hydroxycarbamide

22/03/1966 21/03/2014 19/06/2014

No, except if

required nationally

by a competent

authority

Other

ibuprofen 19/02/1969 18/02/2014 19/05/2014 Yes Otheribuprofen, pseudoephedrine 18/09/1989 18/07/2013 16/10/2013 Yes Othericodextrin

Not Available* 30/04/2014 29/07/2014

No, except if

required nationally

by a competent

authority

Other

ifenprodil

19740306 201303 201306

No, except if

required nationally

by a competent

authority

Other

indapamide, perindopril

30/08/2001 24/10/2013 22/01/2014

No, except if

required nationally

by a competent

authority

Other

influenza vaccine (H1N1)ν

(split virion, inactivated) 15/09/2009 29/11/2013 27/02/2014

No, except if

required nationally

by a competent

authority

Other

influenza vaccine (H1N1)ν

(surface antigens,

inactivated, prepared in cell

cultures, adjuvanted)

04/11/2009 31/05/2013 29/08/2013

No, except if

required nationally

by a competent

authority

Other

influenza vaccine (surface

antigen, inactivated)

23/04/2000 30/04/2013

Vaccine covered by the EURD

list entry "Seasonal influenza

vaccines ". Therefore deletion

from the PSUR WS list required

Seasonal influenza

vaccines:

PSUR frequency of

8 months from

1/9/2012 to

30/04/2013 and 4

months from

01/05/13 to

31/08/2013

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other


antigen, inactivated,

virosome)

Not Available* 30/04/2013





Seasonal influenza

vaccines:

PSUR frequency of

8 months from

1/9/2012 to

30/04/2013 and 4

months from

01/05/13 to

31/08/2013

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

246

247

248

249

250

influenza vaccine (whole

virion, inactivated)

01/11/1970 30/04/2013





Seasonal influenza

vaccines:

PSUR frequency of

8 months from

1/9/2012 to

30/04/2013 and 4

months from

01/05/13 to

31/08/2013

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other

influenza vaccine (split virion,

inactivated) - (non centrally

authorised products)

08/08/1996 30/04/2013 Novartis

PSURs for seasonal

influenza vaccines will be

assessed separately: at

national level for

National/MRP/DCP

products and by the

PRAC for Centrally

Authorised Products

This entry notably covers

Begrivac, Fluarix alpha-

Rix Influsplit SSW, Fluarix

Tetra, Vaxigrip, Afluria,

Mutagrip

Seasonal influenza

vaccines

PSUR frequency of

8 months from 1st

September 30th

April and 4 months

from 1st May to

31st August

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other

influenza vaccine (split virion,

inactivated, prepared in cell

cultures)

20/09/2010 30/04/2013 BAXTER S.P.A

PSURs for seasonal



national level for

National/MRP/DCP

products and by the

PRAC for Centrally

Authorised Products


Preflucel

Seasonal influenza

vaccines

PSUR frequency of

8 months from 1st

September 30th

April and 4 months

from 1st May to

31st August

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other



virosome)

31/10/2001 30/04/2013CRUCELL ITALY

S.R.L.

PSURs for seasonal



national level for

National/MRP/DCP

products and by the

PRAC for Centrally

Authorised Products


ISIFLU and INFLEXAL V

Seasonal influenza

vaccines

PSUR frequency of

8 months from 1st

September 30th

April and 4 months

from 1st May to

31st August

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other



adjuvanted)

23/04/2000 30/04/2013 Novartis

PSURs for seasonal



national level for

National/MRP/DCP

products and by the

PRAC for Centrally

Authorised Products


FLUAD

Seasonal influenza

vaccines

PSUR frequency of

8 months from 1st

September 30th

April and 4 months

from 1st May to

31st August

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

251

252

253

254

255

256

257

258

259

260

261

262

263

264


antigen, inactivated)

16/02/1998 30/04/2013Abbott

Biologicals B.V.

PSURs for seasonal



national level for

National/MRP/DCP

products and by the

PRAC for Centrally

Authorised Products


Influvac, Xanaflu, Vaccino

Influenzale Novartis,

FLUVIRIN, Vacciflu,

Batrevac, AGRIPPAL

Seasonal influenza

vaccines

PSUR frequency of

8 months from 1st

September 30th

April and 4 months

from 1st May to

31st August

31/08/2013 09/07/2013

No, except if

required nationally

by a competent

authority

Other

inosine dimepranol acedoben

01/08/1978 01/08/2013 30/10/2013

No, except if

required nationally

by a competent

authority

Other

ipratropium

14/08/1974 20/11/2013Boehringer

Ingelheim

HU kindly volunteered to

act as P-RMSHU/H/PSUR0034/001 18/02/2014

No, except if

required nationally

by a competent

authority

Work Sharing

ipratropium, salbutamol

22/03/1994 14/01/2014HU kindly volunteered to

act as P-RMSHU/H/PSUR0035/001 14/04/2014

No, except if

required nationally

by a competent

authority

Work Sharing

isoniazide, rifampicin

01/05/1968 01/05/2013 30/07/2013

No, except if

required nationally

by a competent

authority

Other

ispaghula husk + mebeverine

201302 201305

No, except if

required nationally

by a competent

authority

Other

itopride

30/06/1995 30/06/2013 28/09/2013

No, except if

required nationally

by a competent

authority

Other

lactobacillus acidophilus

01/01/1983 30/06/2014 28/09/2014

No, except if

required nationally

by a competent

authority

Other

lactobacillus fermentum,

lactobacillus rhamnosus,

lactobacillus salivarius,

lactobacillus vaginalis

Not Available* 30/06/2014 28/09/2014

No, except if

required nationally

by a competent

authority

Other

lanthanum carbonate hydrate

Not Available* 18/03/2014 16/06/2014

No, except if

required nationally

by a competent

authority

Other

lenograstim 11/10/1991 31/10/2013 29/01/2014 Yes Otherlevodopa Not Available* 31/10/2013 29/01/2014 Yes Otherlevosalbutamol

Not Available* 31/01/2014

Deletion of this entry as

levosalbutamol has been

merged with salbutamol

01/05/2014

No, except if

required nationally

by a competent

authority

Other

lithium

19670220 201302 201305

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

265

266

267

268

269

270

271

272

273

274

275

276

277

278

279

280

281

282

283

lynestrenol

19730320 201303 201306

No, except if

required nationally

by a competent

authority

Other

macrogol 3350

15/04/1991 31/05/2013 29/08/2013

No, except if

required nationally

by a competent

authority

Other

mannitol

Not Available* 28/02/2014 29/05/2014

No, except if

required nationally

by a competent

authority

Other

measles vaccine (live

attenuated) 25/10/1966 04/05/2014 02/08/2014

No, except if

required nationally

by a competent

authority

Other

mebeverine

19641110 201302 201305

No, except if

required nationally

by a competent

authority

Other

meprobamate

25/07/1963 31/10/2013 29/01/2014

No, except if

required nationally

by a competent

authority

Other

methadone

01/01/1930 01/05/2013 30/07/2013

No, except if

required nationally

by a competent

authority

Other

methionine

20010718 201303 201306

No, except if

required nationally

by a competent

authority

Other

methotrexate 01/01/1962 30/06/2014 28/09/2014 Yes Othermethoxsalen

19580331 201303 201306

No, except if

required nationally

by a competent

authority

Other

methylphenobarbital

201303 201306

No, except if

required nationally

by a competent

authority

Other

midodrine

06/02/1974 06/06/2013 04/09/2013

No, except if

required nationally

by a competent

authority

Other

mifepristone 31/05/1988 31/05/2013 29/08/2013 Yes Othermitoxantrone 15/06/1981 30/06/2013 28/09/2013 Yes Othermuromonab-cd3

03/06/1986 15/05/2013 13/08/2013

No, except if

required nationally

by a competent

authority

Other

nalbuphine 15/05/1979 01/05/2013 30/07/2013 Yes Othernaproxen

04/08/1961 03/08/2014 01/11/2014

No, except if

required nationally

by a competent

authority

Other

neostigmine

19320701 201303 201306

No, except if

required nationally

by a competent

authority

Other

nicotinic acid, simvastatin Not Available* 01/07/2013 29/09/2013 Yes Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

284

285

286

287

288

289

290

291

292

293

294

295

296

297

298

299

300

nifuratel

19650504 201302 201305

No, except if

required nationally

by a competent

authority

Other

nifuratel + nystatin

19761012 201303 201306

No, except if

required nationally

by a competent

authority

Other

nitrazepam

19650302 201303 201306

No, except if

required nationally

by a competent

authority

Other

nitrofurantoin

19530228 201302 201305

No, except if

required nationally

by a competent

authority

Other

nitrous oxide

Not Available* 03/03/2014 01/06/2014

No, except if

required nationally

by a competent

authority

Other

olpadronic acid

Not Available* 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other

opium prepared, paracetamol

12/10/2010 30/09/2013 29/12/2013

No, except if

required nationally

by a competent

authority

Other

oxytocin

02/06/1955 30/06/2014 28/09/2014

No, except if

required nationally

by a competent

authority

Other

pancuronium 01/01/1991 01/12/2013 01/03/2014 Yes Otherpanthenol

201303 201306

No, except if

required nationally

by a competent

authority

Other

paracetamol combinations

with acetyl salicylic acid201302

Deletion of the entries

"Substance +

combinations" as it

causes confusion for

stakeholders

201305

No, except if

required nationally

by a competent

authority

Other

patent blue V sodium 31/03/1974 30/04/2013 29/07/2013 Yes Otherpentoxyverine

15/12/1954 31/12/2013 31/03/2014

No, except if

required nationally

by a competent

authority

Other

perphenazine

19521015 201302 201305

No, except if

required nationally

by a competent

authority

Other

pethidine

19410328 201303 201306

No, except if

required nationally

by a competent

authority

Other

phendimetrazine

201303 201306

No, except if

required nationally

by a competent

authority

Other

phenylbutazone

19520219 201302 201305

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

301

302

303

304

305

306

307

308

309

310

311

312

313

pilocarpine + timolol

19890213 201302 201305

No, except if

required nationally

by a competent

authority

Other

pimozide

19710215 201302 201305

No, except if

required nationally

by a competent

authority

Other

pipobroman

01/07/1966 30/06/2013 28/09/2013

No, except if

required nationally

by a competent

authority

Other

pipotiazine

19720321 201303 201306

No, except if

required nationally

by a competent

authority

Other

pirenzepine

19790213 201303 201306

No, except if

required nationally

by a competent

authority

Other

pitavastatin

17/07/2003 16/07/2013 14/10/2013

No, except if

required nationally

by a competent

authority

Other

pristinamycin

19610327 201303 201306

No, except if

required nationally

by a competent

authority

Other

protirelin

01/01/1974 01/01/2014 01/04/2014

No, except if

required nationally

by a competent

authority

Other

pyrazinamide

19560125 201302 201305

No, except if

required nationally

by a competent

authority

Other

quinine

15/01/1951 30/11/2013 28/02/2014

No, except if

required nationally

by a competent

authority

Other

racecadotril

Not Available* 31/03/2014 29/06/2014

No, except if

required nationally

by a competent

authority

Other

reviparin

05/07/2001 04/07/2013

Following the last PSUR

WS assessment

(DE/H/PSUR/0045/001),

the next DLP will be

14/01/2015. The

substance was therefore

moved to the EURD list in

line with the document

"Assessment of Periodic

Safety Update Reports

for National Authorised"

02/10/2013

No, except if

required nationally

by a competent

authority

Other

saccharomyces boulardii

Not Available* 07/02/2014 08/05/2014

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

314

315

316

317

318

319

320

321

322

323

324

325

326

327

328

329

330

levosalbutamol / salbutamol

31/01/1969 31/01/2014 01/05/2014

No, except if

required nationally

by a competent

authority

Other

secnidzole

19730605 201303 201306

No, except if

required nationally

by a competent

authority

Other

sotalol

22/08/1973 21/08/2014 19/11/2014

No, except if

required nationally

by a competent

authority

Other

stibogluconate

19660330 201303 201306

No, except if

required nationally

by a competent

authority

Other

suxamethonium 14/08/1952 13/08/2014 11/11/2014 Yes Othertechnetium (99mTc)

oxidronate 19830321 201303 201306

No, except if

required nationally

by a competent

authority

Other

technetium (99mTc)

pertechnetate Not Available* 27/03/2014 25/06/2014

No, except if

required nationally

by a competent

authority

Other

testosterone undecylate

injection 25/11/2003 24/11/2013 22/02/2014

No, except if

required nationally

by a competent

authority

Other

thiocolchicoside

19560704 201303 201306

No, except if

required nationally

by a competent

authority

Other

thioridazine

19590201 201302 201305

No, except if

required nationally

by a competent

authority

Other

thyrotropine releasing

hormone (synthetic) 19790501 201302 201305

No, except if

required nationally

by a competent

authority

Other

tick-borne encephalitis

Vaccine (inactivated) 29/01/2001 31/01/2014 01/05/2014

No, except if

required nationally

by a competent

authority

Other

tinzaparine

19910228 201302 201305

No, except if

required nationally

by a competent

authority

Other

tosylchloramide

201303 201306

No, except if

required nationally

by a competent

authority

Other

tramadol 18/04/1973 22/05/2014 20/08/2014 Yes Othertreprostinil

21/05/2002 21/05/2013

DLP changed from

01/05/2013 following

request from the

innovator company to

align DLP with IBD

19/08/2013 Yes Other

triamcinolone (intraocular

formulations) 31/03/2011 31/03/2014

Name of the formulation

changed from "ophtalmic"

to "intraocular"

yearly PSURs 29/06/2014

No, except if

required nationally

by a competent

authority

Other


2



Innovator brand

name (for fixed

combination

products only)

EU HBDDLP (year


Allocated P-RMS /

Procedure number

Note on PSUR

cycleNext DLP

Submission of

PSURs by

(DLP + 90

days by

default)

Are PSURs

required for

products referred

to in Articles

10(1), 10a, 14 and

16a of Directive

2001/83/EC as

amended?


Work Sharing scheme



Products including

MRP/DCP)

331

332

333

334

335

336

337

338

339

340

trifluridine

201303 201306

No, except if

required nationally

by a competent

authority

Other

trimeperidine

Not Available* 28/08/2013 26/11/2013

No, except if

required nationally

by a competent

authority

Other

trimetazidine 06/08/2001 06/08/2013 04/11/2013 Yes Othertyphoid polysaccharide

vaccine 05/08/1998 05/08/2014 03/11/2014

No, except if

required nationally

by a competent

authority

Other

typhoid vaccine (live,

attenuated) 12/12/1984 02/07/2014 30/09/2014

No, except if

required nationally

by a competent

authority

Other

varicella vaccine (live)

17/10/1994 17/10/2013

Request from Sanofi to

change the DLP to

16/03/2014 and PSUR

frequency to 1 year.

The request will be

considered by the RMS of

Viravax during the on-

going PSUR assessment

26/12/2013

No, except if

required nationally

by a competent

authority

Other

varicella zoster-

immunoglobine 29/12/1995 31/12/2013 31/03/2014

No, except if

required nationally

by a competent

authority

Other

vincristine

19950412 201303 201306

No, except if

required nationally

by a competent

authority

Other

yellow fever vaccine (live)

27/01/1986 02/12/2013 02/03/2014

No, except if

required nationally

by a competent

authority

Other

yohimbine 01/06/1944 31/05/2013 29/08/2013 Yes Other


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