quetiapine: list of nationally authorised medicinal ... · active substance(s): quetiapine ....

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

12 April 2018 EMA/221551/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): quetiapine

Procedure No.: PSUSA/00002589/201707

http://www.ema.europa.eu/contact

EMA/221551/2018 Page 2/46

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SEROQUEL 25 mg filmsko obložene tablete

NL/H/0156/001 H/99/01407/001 ASTRAZENECA UK LIMITED SI



SEROQUEL 100 mg filmom obložene tablete

NL/H/0156/002 HR-H-461808155 ASTRAZENECA D.O.O. HR





Seroquel 25 mg comprimidos revestidos por película

NL/H/0156/001 3073681 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA

PT



PT



PT

SEROQUEL 25 mg, comprimés pelliculés

NL/H/0156/001 2010010629 ASTRAZENECA S.A. / N.V. LU

Seroquel® 100 mg tabletti, kalvopäällysteinen

NL/H/0156/002 14758 ASTRAZENECA OY FI



PT



PT

Seroquel 25 mg film-coated tablets NL/H/0156/001 PL 17901/0038 ASTRAZENECA UK LIMITED UK Seroquel 25 mg comprimidos revestidos por película


PT



Seroquel, 100 mg õhukese polümeerikattegatabletid

NL/H/0156/002 257199 ASTRAZENECA UK LIMITED EE

Seroquel 100 mg plėvele dengtos tabletės

NL/H/0156/002 LT/1/99/0294/002 ASTRAZENECA UK LIMITED LT



EMA/221551/2018 Page 3/46






Seroquel 100 mg film-coated tablets

NL/H/0156/002 PL 17901/0039 ASTRAZENECA UK LIMITED UK

Seroquel, 200 mg õhukese polümeerikattega tabletid




Seroquel 200 mg επικαλυμμένα με λεπτό υμένιο δισκία

NL/H/0156/003 17718 ASTRAZENECA UK LIMITED CY

Seroquel 100 mg Filmtabletten NL/H/0156/002 1-23461 ASTRAZENECA OSTERREICH GMBH

AT






AT

Seroquel® 200 mg Filmtabletten NL/H/0156/003 47291.02.00 ASTRAZENECA GMBH DE Seroquel 200 mg comprimidos revestidos por película


PT



PT



PT



PT



PT



PT


AT



PT



EMA/221551/2018 Page 4/46








PT



Seroquel® 25 mg Filmtabletten NL/H/0156/001 47291.00.00 ASTRAZENECA GMBH DE Seroquel 25 mg plėvele dengtos tabletės




PT



PT



PT



PT



PT



PT





PT



PT





PT





PT


AT

EMA/221551/2018 Page 5/46








PT



PT



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PT



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PT


AT



PT



PT



PT



PT

Seroquel 300 mg comprimidos NL/H/0156/007 3735180 ASTRAZENECA PRODUTOS PT

EMA/221551/2018 Page 6/46






revestidos por película FARMACEUTICOS LDA Seroquel 300 mg comprimidos revestidos por película


PT



PT



PT



PT



PT



SEROQUEL 25 mg compresse rivestite con film

NL/H/0156/001 A.I.C 32944112 ASTRAZENECA S.P.A. IT



Seroquel 150 mg filmdragerade tabletter

NL/H/0156/006 18964 ASTRAZENECA AB SE

Seroquel®-100, filmomhulde tabletten

NL/H/0156/002 RVG 20827 ASTRAZENECA BV NL


NL/H/0156/003 BE210375 ASTRAZENECA S.A. / N.V. BE


NL/H/0156/006 32944086 ASTRAZENECA S.P.A. IT

SEROQUEL 200 mg, filmomhulde tabletten



NL/H/0156/003 PA 970/18/3 ASTRAZENECA UK LIMITED IE







EMA/221551/2018 Page 7/46















NL/H/0156/003 MA044/00103 ASTRAZENECA UK LIMITED MT









Seroquel 25 mg film-coated tablets NL/H/0156/001 PA 970/18/1 ASTRAZENECA UK LIMITED IE Seroquel®-200, filmomhulde tabletten




Seroquel 25 mg film-coated tablets NL/H/0156/001 MA044/00101 ASTRAZENECA UK LIMITED MT Seroquel 25 mg filmdragerade tabletter





NL/H/0156/002 MA044/00102 ASTRAZENECA UK LIMITED MT





SEROQUEL 25 mg, filmomhulde NL/H/0156/001 BE210357 ASTRAZENECA S.A. / N.V. BE

EMA/221551/2018 Page 8/46






tabletten SEROQUEL 300 mg, filmomhulde tabletten














Seroquel 25 mg comprimidos recubiertos con película

NL/H/0156/001 63.054 ASTRAZENECA FARMACÉUTICA SPAIN, S.A.

ES



ES



ES

Seroquel, filmovertrukne tabletter NL/H/0156/003 32336 ASTRAZENECA A/S DK Seroquel, filmovertrukne tabletter NL/H/0156/002 32335 ASTRAZENECA A/S DK Seroquel 300 mg comprimidos recubiertos con película


ES

Seroquel, filmovertrukne tabletter NL/H/0156/001 32334 ASTRAZENECA A/S DK Seroquel, filmovertrukne tabletter NL/H/0156/007 32600 ASTRAZENECA A/S DK Seroquel, filmovertrukne tabletter NL/H/0156/006 32599 ASTRAZENECA A/S DK Seroquel 100 mg filmdrasjerte tabletter

NL/H/0156/002 02-1436 ASTRAZENECA AS NO

Seroquel 200 mg filmdrasjerte tabletter


Seroquel 300 mg filmdrasjerte tabletter


Seroquel 150 mg filmdrasjerte NL/H/0156/006 02-1437 ASTRAZENECA AS NO

EMA/221551/2018 Page 9/46






tabletter Seroquel 25 mg filmdrasjerte tabletter


Seroquel 100 mg filmuhúðaðar töflur

NL/H/0156/002 IS/1/03/002/02 ASTRAZENECA AB IS





Seroquel 25 mg filmuhúðaðar töflur NL/H/0156/001 IS/1/03/002/01 ASTRAZENECA AB IS Seroquel 300 mg filmuhúðaðar töflur




Seroquel 100 mg plevele dengtos tabletes


Seroquel 100 mg filmsko obložene tablete


















Seroquel 25 mg filmsko obložene NL/H/0156/001 H/99/01407/004 ASTRAZENECA UK LIMITED SI

EMA/221551/2018 Page 10/46






tablete Seroquel 25 mg filmsko obložene tablete






PT



PT

Seroque1 100 mg επικαλυμμένα με λεπτό υμένιο δισκία

NL/H/0156/002 54573/15-06-2017 ASTRAZENECA S.A GR







Seroque1150 mg επικαλυμμένα με λεπτό υμένιο δισκία


SEROQUEL Starter Pack, filmomhulde tabletten (combinatieverpakking)


SEROQUEL Starter Pack, comprimés pelliculés (emballage combiné)



NL/H/0156/002 A.I.C. 032944213 ASTRAZENECA S.P.A. IT









SEROQUEL 150 mg compresse NL/H/0156/006 A.I.C. 032944314 ASTRAZENECA S.P.A. IT

EMA/221551/2018 Page 11/46






rivestite con film SEROQUEL 150 mg compresse rivestite con film


































EMA/221551/2018 Page 12/46




















Seroquel Embalagem de início de 3 Dias (25 mg) + (100 mg) comprimidos revestidos por película


PT

SEROQUEL 4-day Starter Pack, comprimés pelliculés


SEROQUEL 4-day Starter Pack, filmomhulde tabletten


SEROQUEL Starter Pack, comprimés pelliculés


Seroquel, filmovertrukne tabletter NL/H/0156/005 32337 ASTRAZENECA A/S DK Seroquel Confezione Starter 4-Giorni


SEROQUEL 4-day Starter Pack, comprimés pelliculés


Seroquel Embalagem de início de 4 Dias (25 mg) + (100 mg) + (200 mg) comprimidos revestidos por película


PT

Seroquel Confezione Starter 3-Giorni (confezione combinata)

NL/H/0156/004 A.I.C. 032944478 ASTRAZENECA BV IT

SEROQUEL 300 mg compresse NL/H/0156/007 A.I.C. 032944439 ASTRAZENECA S.P.A. IT

EMA/221551/2018 Page 13/46






rivestite con film SEROQUEL 100 mg filmsko obložene tablete


SEROQUEL μικτή συσκευασία έναρξης θεραπείας 3 ημερών (3 Day Starterpack)


SEROQUEL μικτή συσκευασία έναρξης θεραπείας 4 ημερών (4 Day Starterpack)




Q Mind 150 mg comprimate filmate DE/H/2610/004/DC 8352/2015/01-04 TORRENT PHARMA SRL RO Quetiapin Heumann 50 mg Filmtabletten

DE/H/2610/002 79951.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG

DE

Quetiapin Heumann 150 mg Filmtabletten

DE/H/2610/004/DC 79953.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG

DE

Quetiapin Heumann 400 mg Filmtabletten

DE/H/2610/007/DC 79956.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG

DE

Alzen SR 150 mg comprimidos de libertação prolongada

PT/H/1439/002 5176953 ASTRAZENECA PRODUTOS FARMACEUTICOS LDA

PT



PT



PT



PT



PT



PT



PT



PT

Alzen SR 300 mg comprimidos de PT/H/1439/004 5090915 ASTRAZENECA PRODUTOS PT

EMA/221551/2018 Page 14/46






libertação prolongada FARMACEUTICOS LDA Alzen SR 200 mg comprimidos de libertação prolongada


PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT



PT

XeroquelÒ LP 300 mg, comprimé à libération prolongée

NL/H/1983/004 NL 39 380 ASTRAZENECA S.A.S. FR

EMA/221551/2018 Page 15/46










Quetiapine XR AstraZeneca 150 mg, tabletten met verlengde afgifte










Seroquel SR 400 mg tablete s podaljšanim sproščanjem














Seroquel XR 200 mg tablety s predĺženým uvoľňovaním

NL/H/0156/009 68/0231/07-S ASTRAZENECA UK LIMITED SK

Seroquel XR 50 mg tablete s produljenim oslobađanjem




Seroquel XR 300 mg tablete s NL/H/0156/010 HR-H-408184728 ASTRAZENECA BV HR

EMA/221551/2018 Page 16/46






produljenim oslobađanjem Seroquel XR 400 mg tablete s produljenim oslobađanjem




SEROQUEL XR 150 mg δισκία παρατεταμένης αποδέσμευσης


Seroquel Prolong 150 mg depottabletti




Seroquel XR, 300 mg toimeainet prolongeeritult vabastavad tabletid


Seroquel SR 200 mg comprimidos de libertação prolongada


PT



PT









PT



PT





PT



PT

Seroquel XR, 400 mg toimeainet prolongeeritult vabastavad tabletid


EMA/221551/2018 Page 17/46










PT



PT





PT



SEROQUEL XR 150 mg, tabletten met verlengde afgifte


Seroquel XR 150 mg Retardtabletten

NL/H/0156/012 1-28377 ASTRAZENECA OSTERREICH GMBH

AT

Seroquel Prolong® 150 mg Retardtabletten

NL/H/0156/012 73290.00.00 ASTRAZENECA GMBH DE

SEROQUEL XR 150 mg, comprimé à libération prolongée




AT









AT





Seroquel XR 50 mg Retardtabletten NL/H/0156/008 1-27420 ASTRAZENECA OSTERREICH AT

EMA/221551/2018 Page 18/46






GMBH SEROQUEL XR 50 mg, tabletten met verlengde afgifte








Seroquel XR 50 mg pailginto atpalaidavimo tabletės


Seroquel 50 mg compresse a rilascio prolungato

not available 32944124 ASTRAZENECA S.P.A. IT

Seroquel XR 50 mg, comprimés à libération prolongée


Seroquel XR 50 mg prolonged-release tablets




















EMA/221551/2018 Page 19/46












Seroquel XR® 400 mg, tabletten met verlengde afgifte


Seroquel Depot 50 mg depottabletter






Seroquel XL 400 mg prolonged-release tablets


Seroquel XL 50 mg prolonged-released tablets









NL/H/0156/012 17901/0259 ASTRAZENECA UK LIMITED UK







Seroquel Prolong 400 mg comprimidos de liberación prolongada


ES

EMA/221551/2018 Page 20/46






Seroquel XR 50 mg retard tabletta NL/H/0156/008 OGYI-T-5863/02 ASTRAZENECA KFT. HU Seroquel Prolong 50 mg comprimidos de liberación prolongada


ES

Seroquel XR 300 mg retard tabletta NL/H/0156/010 OGYI-T-5863/04 ASTRAZENECA KFT. HU Seroquel Prolong 150 mg comprimidos de liberación prolongada


ES



ES

Seroquel XR 400 mg retard tabletta NL/H/0156/011 OGYI-T-5863/05 ASTRAZENECA KFT. HU Seroquel XR 150 mg retard tabletta NL/H/0156/012 OGYI-T-5863/08 ASTRAZENECA KFT. HU Seroquel XR 150 mg retard tabletta NL/H/0156/012 OGYI-T-5863/09 ASTRAZENECA KFT. HU Seroquel Prolong, depottabletter NL/H/0156/010 42033 ASTRAZENECA A/S DK Seroquel Prolong, depottabletter NL/H/0156/011 42034 ASTRAZENECA A/S DK Seroquel Prolong, depottabletter NL/H/0156/008 42031 ASTRAZENECA A/S DK Seroquel Prolong, depottabletter NL/H/0156/012 43173 ASTRAZENECA A/S DK Seroquel Depot 150 mg depottabletter










Seroquel Prolong 150 mg forðatöflur

NL/H/0156/012 IS/1/08/081/01 ASTRAZENECA A/S IS





Seroquel Prolong 400 mg NL/H/0156/011 IS/1/08/003/04 ASTRAZENECA A/S IS

EMA/221551/2018 Page 21/46






forðatöflur Seroquel Prolong 50 mg forðatöflur NL/H/0156/008 IS/1/08/003/01 ASTRAZENECA A/S IS Seroquel XR 50 mg retard tabletta NL/H/0156/008 OGYI-T-5863/10 ASTRAZENECA KFT. HU Seroquel XR 400 mg retard tabletta NL/H/0156/011 OGYI-T-5863/16 ASTRAZENECA KFT. HU Seroquel XR 200 mg retard tabletta NL/H/0156/009 OGYI-T-5863/11 ASTRAZENECA KFT. HU Seroquel XR 300 mg retard tabletta NL/H/0156/010 OGYI-T-5863/15 ASTRAZENECA KFT. HU Seroquel XR 400 mg retard tabletta NL/H/0156/011 OGYI-T-5863/13 ASTRAZENECA KFT. HU Seroquel XR 200 mg retard tabletta NL/H/0156/009 OGYI-T-5863/14 ASTRAZENECA KFT. HU Seroquel XR 150 mg comprimate cu eliberare prelungita

NL/H/0156/012 9529/2016/01 ASTRAZENECA UK LIMITED RO

Seroquel XR 150 mg comprimate cu eliberare prelungita
























Seroquel XR 300 mg comprimate cu NL/H/0156/010 9531/2016/04 ASTRAZENECA UK LIMITED RO

EMA/221551/2018 Page 22/46






eliberare prelungita Seroquel XR 300 mg comprimate cu eliberare prelungita


































EMA/221551/2018 Page 23/46




















Seroquel XR 300 mg retard tabletta NL/H/0156/010 OGYI-T-5863/12 ASTRAZENECA KFT. HU SEROQUEL XR 200 mg, comprimé à libération prolongée




Seroquel Prolong, depottabletter NL/H/0156/009 42032 ASTRAZENECA A/S DK Seroquel Prolong 200 mg depottabletti


Seroquel Prolong® 200 mg Retardtabletten Wirkstoff: Quetiapin












Seroquel SR 300 mg tablete s NL/H/0156/010 H/99/01407/066 ASTRAZENECA UK LIMITED SI

EMA/221551/2018 Page 24/46






podaljšanim sproščanjem Seroquel SR 150 mg tablete s podaljšanim sproščanjem


































EMA/221551/2018 Page 25/46




















Seroquel XR 200 mg retard tabletta NL/H/0156/009 OGYI-T-5863/03 ASTRAZENECA KFT. HU Seroquel SR 150 mg comprimidos de libertação prolongada


PT




NL/H/0156/009 54581/15.06.2017 ASTRAZENECA S.A GR











ES



Seroquel 150 mg compresse a NL/H/0156/012 A.I.C. 032944542 ASTRAZENECA S.P.A. IT

EMA/221551/2018 Page 26/46






rilascio prolungato Seroquel 150 mg compresse a rilascio prolungato


































EMA/221551/2018 Page 27/46




















Kvelux 300 mg filmsko obložene tablete

DK/H/1527/004 H/09/01997/030 LEK PHARMACEUTICALS D.D. LJUBLJANA

SI



SI



SI



SI



SI



SI



SI



SI



SI



SI

Kvelux 300 mg filmsko obložene DK/H/1527/004 H/09/01997/040 LEK PHARMACEUTICALS D.D. SI

EMA/221551/2018 Page 28/46






tablete LJUBLJANA Kvelux 300 mg filmsko obložene tablete


SI



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EMA/221551/2018 Page 29/46








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Kvelux 50 mg filmsko obložene DK/H/1430/002 H/09/01933/018 LEK PHARMACEUTICALS D.D. SI

EMA/221551/2018 Page 30/46






tablete LJUBLJANA Kvelux 50 mg filmsko obložene tablete


SI



SI



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EMA/221551/2018 Page 31/46








SI

Quetiapin 1A Pharma 100 mg - Filmtabletten

DK/H/1529/001 1-29169 1A PHARMA GMBH AT

Quetiapin Sandoz 50 mg – Filmtabletten

DK/H/1430/002 1-28698 SANDOZ GMBH AT

















Quetiapin HEXAL 100 mg Filmtabletten

DK/H/1528/001 73558.00.00 HEXAL AG DE

Quetiapin - 1 A Pharma 100 mg Filmtabletten

DK/H/1529/001 73497.00.00 1 A PHARMA GMBH DE


DK/H/1528/002 73559.00.00 HEXAL AG DE


DK/H/1528/003 73560.00.00 HEXAL AG DE




DK/H/1528/004 73561.00.00 HEXAL AG DE

Quetiapin - 1 A Pharma 300 mg DK/H/1529/004 73500.00.00 1 A PHARMA GMBH DE

EMA/221551/2018 Page 32/46






Filmtabletten Quetiapin - 1 A Pharma 400 mg Filmtabletten



DK/H/1431/002 71239.00.00 HEXAL AG DE




DK/H/1528/005 73562.00.00 HEXAL AG DE

Quetiapine 200 mg Film-coated Tablets

DK/H/1527/003 PL 04416/0964 SANDOZ LTD UK







QUETIAPINE SANDOZ 300 MG, FILMOMHULDE TABLETTEN

DK/H/1527/004 RVG 102993 SANDOZ B.V. NL

Quetiapine Sandoz 200 mg, filmomhulde tabletten


Quetiapin "Sandoz" DK/H/1430/002 42919 SANDOZ A/S DK Quetiapin "1A Farma" DK/H/1432/002 42923 1A FARMA A/S DK Seresano DK/H/1431/002 42921 HEXAL A/S DK Quetiapin "Sandoz" DK/H/1527/001 43568 SANDOZ A/S DK Quetiapin "Sandoz" DK/H/1527/002 43569 SANDOZ A/S DK Quetiapin "Sandoz" DK/H/1527/003 43570 SANDOZ A/S DK Quetiapin "Sandoz" DK/H/1527/004 43571 SANDOZ A/S DK Seresano, filmovertrukne tabletter 100 mg

DK/H/1528/001 43573 HEXAL A/S DK

Seresano, filmovertrukne tabletter 150 mg

DK/H/1528/002 43574 HEXAL A/S DK


DK/H/1528/003 43575 HEXAL A/S DK

Seresano, filmovertrukne tabletter DK/H/1528/004 43576 HEXAL A/S DK

EMA/221551/2018 Page 33/46






300 mg Quetiapin ”1A Farma”, filmovertrukne tabletter 100 mg

DK/H/1529/001 43582 1A FARMA A/S DK

Quetiapin "1A Farma", filmovertrukne tabletter 150 mg

DK/H/1529/002 43583 1A FARMA A/S DK


DK/H/1529/003 43584 1A FARMA A/S DK


DK/H/1529/004 43585 1A FARMA A/S DK


DK/H/1528/005 43577 HEXAL A/S DK


DK/H/1529/005 43586 1A FARMA A/S DK

Quetiapin Sandoz 100 mg kalvopäällysteinen tabletti

DK/H/1527/001 25268 SANDOZ A/S FI


DK/H/1527/004 25271 SANDOZ A/S FI


DK/H/1527/003 25270 SANDOZ A/S FI

Quetiapin Sandoz 100 mg filmdragerade tabletter

DK/H/1527/001 27752 SANDOZ A/S SE

Quetiapin Sandoz 200 mg filmdragerade tabletter

DK/H/1527/003 27754 SANDOZ A/S SE

Quetiapina Sandoz GmbH 100 mg compresse rivestite con film

DK/H/1527/001 040968012 SANDOZ GMBH IT











EMA/221551/2018 Page 34/46








































Quetiapina Sandoz GmbH 200 mg DK/H/1527/003 040968164 SANDOZ GMBH IT

EMA/221551/2018 Page 35/46






compresse rivestite con film Quetiapina Sandoz GmbH 200 mg compresse rivestite con film






























QUETIAPINE SANDOZ 100 MG, FILMOMHULDE TABLETTEN


Quetex 100 mg Film-Coated Tablets DK/H/1528/001 PA 711/156/3 ROWEX LTD IE Quetex 200 mg Film-Coated Tablets DK/H/1528/003 PA 711/156/4 ROWEX LTD IE

EMA/221551/2018 Page 36/46






Quetex 300 mg Film-Coated Tablets DK/H/1528/004 PA 711/156/5 ROWEX LTD IE Quetiapin Sandoz 100 mg – Filmtabletten


Quetiapina Qualigen 50 mg comprimidos recubiertos con película

not available 80989 QUALIGEN, S.L. ES

Tomel 150 mg Film-coated tablets not available 21146 DELORBIS PHARMACEUTICALS LTD

CY

Tomel 300 mg Film-coated tablets not available 21148 DELORBIS PHARMACEUTICALS LTD

CY

Ketilept 300 mg apvalkotās tabletes HU/H/0126/001-005/MR 07-0335 EGIS PHARMACEUTICALS PLC LV Ketilept 150 mg filmtabletta HU/H/0126/003/MR OGYI-T-20056/10, 12 EGIS PHARMACEUTICALS PLC HU Ketilept 150 mg comprimate filmate HU/H/0126/003/MR/E00

1 4214/2012/03-04 EGIS PHARMACEUTICALS PLC RO

Ketilept 300 mg potahované tablety HU/H/0126/001-005/MR 68/255/07-C EGIS PHARMACEUTICALS PLC CZ Ketilept 150 mg filmom obalené tablety

HU/H/0126/003/MR 68/0143/07-S EGIS PHARMACEUTICALS PLC SK

Ketilept 150 mg apvalkotās tabletes HU/H/0126/001-005/MR 07-0333 EGIS PHARMACEUTICALS PLC LV Ketileppt 150 mg filmtabletta HU/H/0126/003/MR OGYI-T-20056/09, 11 EGIS PHARMACEUTICALS PLC HU Psicotric 50 mg comprimidos recubiertos con película

not available 80459 QUALIGEN, S.L. ES

Quetiapine Neuraxpharm 50 mg filmomhulde tabletten

NL/H/1616/006 RVG 110369 NEURAXPHARM ARZNEIMITTEL GMBH

NL

Quetiapin-neuraxpharm 50 mg Filmtabletten

NL/H/1616/006 85926.00.00 NEURAXPHARM ARZNEIMITTEL GMBH

DE

Quetiapin NeuroPharma, 50 mg, tabletki powlekane

NL/H/1616/006 20577 NEURAXPHARM ARZNEIMITTEL GMBH

PL

Quetiapin Lannacher 50 mg-Retardtabletten

not available 1-31091 G.L. PHARMA GMBH AT







EMA/221551/2018 Page 37/46






Quetiapin Rosemont 20 mg/ml mikstur, suspensjon

UK/H/5869/01/DC 14-10296 ROSEMONT PHARMACEUTICALS LIMITED

NO

Quetiapin Rosemont, oral suspension

UK/H/5869/01/DC MTNR. 54693 ROSEMONT PHARMACEUTICALS LIMITED

DK

Quetiapine Rosemont 20mg/ml Oral Suspension

UK/H/5869/01/DC PL 00427/0240 ROSEMONT PHARMACEUTICALS LIMITED

UK

Desiquet 20mg/ml Suspension zum Einnehmen

UK/H/5869/01/DC 93617.00.00 ROSEMONT PHARMACEUTICALS LIMITED

DE


UK/H/5869/01/DC PA 312/028/005 ROSEMONT PHARMACEUTICALS LIMITED

IE

Quetiapine/Rosemont 20mg/ml πόσιμο εναιώρημα

UK/H/5869/01/DC 8988 / 02-02/2017 ROSEMONT PHARMACEUTICALS LIMITED

GR

Quetiapin Gerot 50 mg-Retardtabletten








Quetiapine 150 mg film-coated tablets

PT/H/0604/003 MA807/03008 AUROBINDO PHARMA (MALTA) LIMITED

MT

Quetiapine 300 mg film-coated tablets

PT/H/0604/005 MA807/03010 AUROBINDO PHARMA (MALTA) LIMITED

MT

Quetiapin Rosemont 20 mg/ml mikstur, suspensjon

UK/H/5869/01/DC 14-10296 ROSEMONT PHARMACEUTICALS LIMITED

NO

Quetiapin Rosemont, oral suspension

UK/H/5869/01/DC MTNR. 54693 ROSEMONT PHARMACEUTICALS LIMITED

DK


UK/H/5869/01/DC PL 00427/0240 ROSEMONT PHARMACEUTICALS LIMITED

UK

Desiquet 20mg/ml Suspension zum Einnehmen

UK/H/5869/01/DC 93617.00.00 ROSEMONT PHARMACEUTICALS LIMITED

DE


UK/H/5869/01/DC PA 312/028/005 ROSEMONT PHARMACEUTICALS LIMITED

IE

Quetiapine/Rosemont 20mg/ml UK/H/5869/01/DC 8988 / 02-02/2017 ROSEMONT GR

EMA/221551/2018 Page 38/46






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EMA/221551/2018 Page 39/46






filmate Kventiax 150 mg comprimate filmate


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Quetiapin-ratiopharm® 200 mg Filmtabletten

UK/H/1228/004 2009020018 RATIOPHARM GMBH LU




UK/H/1228/005 70576.00.00 RATIOPHARM GMBH DE



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UK/H/1228/004 08-0340 TEVA PHARMA B.V. LV





EMA/221551/2018 Page 40/46








Quetiapine Teva 25 mg apvalkotās tabletes

UK/H/1228/001 08-0342 TEVA NEDERLAND B.V. LV

Quetiapin-ratiopharm®

quetiapine: list of nationally authorised medicinal ... · active substance(s): quetiapine ....

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