inventory of herbal substances for assessment herbal substances
TRANSCRIPT
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
31 January 2017 EMA/HMPC/494079/2007
Inventory of herbal substances for assessment Herbal substances proposed to HMPC for assessment
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 2/22
Herbal substances proposed to HMPC for assessment
Column A: Herbal substances (working term) proposed for European Union herbal monograph/European Union list entry establishment
Column B: HMPC Total priority after survey among interested parties (IPs) 2005 (AEFMUTA, AESGP, EFCAM, ESCOP, GA, IVAA, PSE) ● mentions with high, medium or not specified priority, ○ mentions with low priority
Column C: Assessment proposal by IPs or National Competent Authorities (NCAs) after 2005 Abbreviation IP or Member State NCA (mm/yy), H=High, M=Medium, L=Low priority
Column D: Added to the HMPC priority list for assessment (EMA/HMPC/278067/2006), Specified date (dd/mm/yyyy)
Related Ph. Eur. monographs on quality
Column E: Related herbal substance monographs on quality in the European Pharmacopoeia Specified monograph term and Ph. Eur. monograph number, (in prep.) = planned or in preparation
Related standards in selected scientific or regulatory publications (monographs of herbal substances with deviating species or plant part are in brackets) Column F: ESCOP monographs × published monographs (2nd ed. including suppl. 2009; individual monographs published online by Jun 2015)
Column G: German Commission E monographs (BfArM) × monographs published successively until 1994 (corrections until 2002)
Column H: French Avis aux fabricants (AFSSAPS) × list entries in Les Cahiers de l’Agence No 3, Les médicaments à base de plantes 1998
Column I: WHO monographs 1 published in Volume 1 (1999), 2 Volume 2 (2002), 3 Volume 3 (2007), 4 Volume 4 (2009), NIS Medicinal plants commonly used in the Newly Independent States (2010)
Column J: Indian monographs a: monograph in the Ayurvedic Pharmacopoeia of India, 1st edition, Part 1, Vol. 1, 2, 3, 4, 5, 6 (2001) b: monograph in the Database on medicinal plants used in Ayurveda, Central council for research in Ayurveda & Siddha, Vol. 1, 2 (2001) c: monograph in the Quality Standards of Indian medicinal plants, Indian Council of Medical Research, Vol. 1, 2, 3, 4, 5, 7, 8 (2003)
Column K: Chinese monographs × monograph in Chinese Pharmacopoeia (PPRC, Vol. 1 Traditional Chinese Materia Medica, 2010)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 3/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Absinthii herba ●●● 23/11/2005 Absinthii herba 1380 × × × (6)
Acori calami rhizoma ● Acori calami rhizoma ad decoctum ad
usum medicinalem sinensem
translaticium 2456 (in prep.)
Acori graminei et acori tatarinowii
rhizomae ad decoctum ad usum
medicinalem sin 2457 (in prep.)
2 1 ×
Adhatodae vasicae
folium
AYUSH (08/08) 12/07/2011 Adhatodae vasicae folium 2738
(in prep.)
1 1
Agni casti fructus ●● 07/09/2007 Agni casti fructus 2147 × × × 4
Agrimoniae herba ● M AESGP (09/10)
10/01/2008 Agrimoniae herba 1587 × × × (×)
Agropyri repentis
rhizoma
● M AESGP (09/10)
10/01/2008 Graminis rhizoma 1306 × × ×
Allii cepae bulbus ○ M AESGP (09/10)
11/03/2010 × 1 3
Allii sativi bulbus ●●●● H AESGP (09/10)
23/11/2005 Allii sativi bulbi pulvis 1216 × × × 1 NIS
3 3 ×
Aloe ●●○ 23/11/2005 Aloe barbadensis 257
Aloe capensis 258
×
×
× 1 1 1 ×
Aloe vera gel ○ Aloe barbadensis 257
Aloe capensis 258
(×) (×) × 1 (1) (1) (×)
Althaeae radix ●●●● 07/09/2006 Althaeae radix 1126
Althaeae folium 1856
× × × 2
NIS
5
Andrographidis herba ○ Andrographis herba 2712 2 8 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 4/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Andrographidis
paniculatae folium
M AESGP (09/10)
27/01/2011 Andrographis herba 2712 (2) (8) (×)
Angelicae sinensis radix ●○ 22/11/2011 Angelicae sinensis radix 2558
Angelicae archangelicae radix 1857
Angelicae dahuricae radix 2556
Angelicae pubescentis radix 2557
2 ×
Anisi aetheroleum 23/11/2005 Anisi aetheroleum 804 (×) (×) (×) 3 (5) (5)
Anisi fructus ●●●●● 23/11/2005 Anisi fructus 262 × × × 3 5 (5)
Arctii folium
(Bardanae folium)
● Arctii radix 2943 (in prep.) × (×)
Arctii radix
(Lappa major radix;
Bardanae radix)
● 06/11/2008 Arctii radix 2943 (in prep.) × (×)
Arnicae flos ●●●● M
AESGP (09/10)
07/09/2007 Arnicae flos 1391 × × × 3
Arnica montana planta
tota
●● Arnicae flos 1391 (×) (×) (×) (3)
Aspidium filix-mas
folium
●
Astragali radix ○ Astragali mongholici radix 2435 1 ×
Avenae fructus 13/07/2006 Avenae sativae seminis pulvis 2539
(in prep.)
Avenae herba 2618 (in prep.)
× ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 5/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Avenae herba ●○ 13/07/2006 Avenae herba 2618 (in prep.)
Avenae sativae seminis pulvis 2539
(in prep.)
× (×)
Bacopae monnierii
herba
AYUSH (08/08) Bacopa monnieri 2850 (in prep.) (2) (1) (8)
Balsamum peruvianum ○ AESGP (07/13) 28/01/2014 Balsamum peruvianum 754
Balsamum tolutanum 1596
×
Betulae folium ●●●●●● 23/11/2005 Betulae folium 1174 × × ×
Boldi folium ●● 23/11/2005 Boldi folium 1396 × × ×
Bruceae fructus ○ 1 ×
Bryophyllum folium =
Kalanchoe pinnata
folium
●●
Bupleuri radix ○ Bupleuri radix 2562 (in prep.) 1 ×
Bursae pastoris herba ○ 06/03/2008 Bursae pastoris herba 2947
(in prep.)
× ×
Calendulae herba ●● (07/13) 28/01/2014 Calendulae flos 1297 (×) × (×) ( 2 )
(NIS)
Calendulae flos ●●●○ 23/11/2005 Calendulae flos 1297 × × × 2
NIS
Camelliae sinensis non
fermentata folia
EDQM (03/11) 31/03/2011 Camelliae sinensis non fermentata
folia 2668 (in prep.)
×
Capsici fructus M AESGP (09/10)
31/03/2011 Capsici fructus 1859
Capsici oleoresina raffinata et
normata 2336
× × × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 6/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Carvi aetheroleum ○ M AESGP (09/10)
06/11/2008 Carvi aetheroleum 1817 (×) × (×) (1) (4)
Carvi fructus ●●●● H AESGP (09/10)
23/11/2005 Carvi fructus 1080 × × × 1 4
Caryophylli floris
aetheroleum
○ 15/07/2010 Caryophylli floris aetheroleum 1091 × × × (2) 6 8 (×)
Caryophylli flos ○ L AESGP (09/10)
12/03/2009 Caryophylli flos 376 (×) × × 2 1 8 ×
Centaurii herba ●●○○ 23/11/2005 Centaurii herba 1301 × × ×
Centellae folium ● Centellae asiaticae herba 1498 (×) (×) (1) (4) (1) (8) (×)
Centellae asiaticae
herba
○ 08/05/2008 Centellae asiaticae herba 1498 × (×) 1 (4) (1) (8) ×
Chamomillae romanae
flos
● H
AESGP (09/10)
16/07/2009 Chamomillae romanae flos 380 × ×
Chelidonii herba ○ 06/11/2008 Chelidonii herba 1861 × × NIS ×
Chelidonium majus
rhizoma
●● Chelidonii herba 1861 (×) (×) (NIS) (×)
Cichorii intybi planta
tota1
Cichorium planta tota
●
○
Cichorii intybi radix 2948 (in prep.) × (×) (3) ×
Cichorii intybi folium2 Cichorii intybi radix 2948 (in prep.) (×) (×) (3) (×)
Cichorii intybi radix 15/01/2009 Cichorii intybi radix 2948 (in prep.) × × 3 ×
1 January 2010: Cancellation of assessment work 2 May 2012: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 7/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Cimicifugae racemosae
rhizoma
●●● 07/09/2006 Cimicifugae rhizoma 2069 × × 2 (×)
Cinnamomi camphorae
folium/cortex3
(07/13) 28/01/2014 Cinnamomi cortex 387 d-Camphora
1400
(×) (6) 3 (×)
Cinnamomi corticis
aetheroleum
11/11/2009 Cinnamomi cassiae aetheroleum 1496
Cinnamomi zeylanici corticis
aetheroleum 1501
Cinnamomi zeylanici folii
aetheroleum 1608
Cinnamomi cortex 387
× (×)
× 1 (1)
6
(1) ×
Cinnamomi cortex ○ 06/11/2008 Cinnamomi cortex 387 × × × 1 1 1 ×
Cinnamomum
camphora, aetherolei
fractio solida
● (07/13) d-Camphora 1400 (×) 6 3 (×)
Cistus creticus,
folium/resinum
(07/13) 28/01/2014
Citri bergami
aetheroleum
M
AESGP (09/10)
11/11/2009 Aurantii amari epicarpium et
mesocarpium 1603
Aurantii amari flos 1810
Aurantii dulcis aetheroleum 1811
× ×
Citrus limon succus ●● 4
Colae semen ● M
AESGP (09/10)
16/07/2009 Colae semen 1504 × × ×
3 September 2015: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 8/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Coptidis rhizoma ○ Coptidis rhizoma 2715
1 ×
Crataegi folium cum
flore
●●● AESGP (05/07)
L
(AESGP 09/10)
13/07/2007 Crataegi folium cum flore 1432 × × × 2
NIS
(×)
Crataegi fructus4 ●● AESGP 05/07
H
(AESGP 09/10)
13/07/2007 Crataegi fructus 1220 × × (×) ( 2 )
(NIS)
(×)
Cucurbitae semen ● 10/01/2008 Cucurbitae semen 2941 (in prep.) × × 4
Curcurmae longae
rhizoma
●●● 23/11/2005 Curcurmae longae rhizoma 2543 × × × 1 1 1 8 ×
Curcumae
zanthorrhizae
rhizoma
●●● H
AESGP (09/10)
06/11/2008 Curcumae zanthorrhizae rhizoma
1441
× × ×
Cyani flos5 ● FR (07/13) 28/01/2014 × ×
Cydonia oblonga
succus
●●
Cynarae folium ●●● 13/07/2006 Cynarae folium 1866 × × × 4
Dryopteris filix-mas IVAA (05/07) × 6
Echinacea angustifolia
planta tota
●● Echinaceae angustifoliae radix 1821 ×
Echinaceae
angustifoliae radix
●● 13/07/2006 Echinaceae angustifoliae radix 1821 × 1
4 May 2014: Cancellation of assessment work 5 November 2014: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 9/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Echinaceae pallidae
radix
●● 13/07/2006 Echinaceae pallidae radix 1822 × × 1
Echinaceae purpureae
herba
●●● 23/11/2005 Echinaceae purpureae herba 1823
Echinaceae purpureae herbae succus
expressus et confirmatus sine
ethanolo 2894 (in prep.)
Echinaceae purpureae herbae succus
expressus et ethanolo confirmatus
2282 (in prep.)
× × 1
Echinacea purpurea
planta tota
● Echinaceae purpureae herba 1823
Echinaceae purpureae radix 1824
(×) (×) (1)
Echinaceae purpureae
radix
● 13/07/2006 Echinaceae purpureae radix 1824 × × (1)
Eleutherococci radix ●● 23/11/2005 Eleutherococci radix 1419 × × × 2
Emblicae officinalis
fructus
AYUSH (08/08) 1 8 ×
Ephedrae herba ○ Ephedrae herba 2451 × 1 ×
Epilobii herba CZ (07/13) 28/01/2014
Equiseti herba ●●○ AESGP (05/06) 13/07/2006 Equiseti herba 1825 × × NIS (×)
Eschscholziae herba
cum flore
22/11/2011 × ×
Eucalypti aetheroleum ● H
AESGP (09/10)
07/09/2007 Eucalypti aetheroleum 390 × × (×) 2 6 (7) ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 10/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Eucalypti folium ●○ H
AESGP (09/10)
07/09/2007 Eucalypti folium 1320 (×) × × 2 5 (7) (×)
Euphrasiae herba ● 06/11/2008 ×
Filipendulae ulmariae
flos
○ 06/03/2008 Filipendulae ulmariae herba 1868 (×) × ×
Filipendulae ulmariae
herba
○ 06/03/2008 Filipendulae ulmariae herba 1868 × × ×
Foeniculi amari fructus ●●●● 23/11/2005 Foeniculi amari fructus 824 × × × 3
NIS
1 ×
Foeniculi amari fructus
aetheroleum
23/11/2005 Foeniculi amari fructus aetheroleum
1826
Foeniculi amari herbae aetheroleum
2380
(×) × (×) ( 3 )
(NIS)
(1) (×)
Foeniculi dulcis fructus 23/11/2005 Foeniculi dulcis fructus 825 × × × 3
NIS
1 ×
Fragaria vesca fructus ○ (×) (×)
Fragariae folium ●●● H
AESGP (09/10)
10/01/2008 × ×
Frangulae cortex ●●○ 23/11/2005 Frangulae cortex 25 × × × 2
Fraxini folium ● L
AESGP (09/10)
16/07/2009 Fraxini folium 1600
Fraxini rhynchophyllae cortex 2452
× × (×)
Fucus vesiculosus ● 13/09/2011 Fucus vel Ascophyllum 1426 × ×
Fumariae herba M
AESGP (09/10)
11/03/2010 Fumariae herba 1869 × × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 11/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Gentianae radix ●●● 07/09/2007 Gentianae radix 392 × × × 3 (×)
Ginkgo bilobae folium ●●● L
AESGP (09/10)
07/09/2007 Ginkgonis folium 1828 × × 1 ×
Ginseng radix ●●● L
AESGP (09/10)
07/09/2007 Ginseng radix 1523 × × × 1
NIS
×
Glycine max and/or
lecithin derived from
Glycine max
(soy bean lecithin)
DE (07/13) 28/01/2014 × ×
Grindeliae herba L
AESGP (09/10)
11/03/2010 Grindeliae herba 2951 (in prep.) × × ×
Hamamelidis cortex ●○ 23/11/2005 Hamamelidis cortex 2532 × × (×) 2
Hamamelidis folium ●○ 23/11/2005 Hamamelidis folium 909 × × × 2
Hamamelidis folium et
cortex aut ramunculus
destillatum
Hamamelidis aqua
●○ 23/11/2005 Hamamelidis aqua 2533 (deleted) × × (×) 2
Harpagophyti radix ●●●● 23/11/2005 Harpagophyti radix 1095 × × × 3
Hederae helicis folium ●●●● 07/09/2007 Hederae folium 2148 × × ×
Helichrysi flos PL (07/13) 28/01/2014 × NIS
Hippocastani cortex ● 06/05/2010 Hippocastani cortex 2945 (in prep.) (×) × × (2) (×)
Hippocastani semen ●●●● 07/09/2006 Hippocastani semen 1830 × × × 2 (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 12/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Hyoscyami herba6 ●● Hyoscyami folium 225 (deleted)
Hyoscyami pulvis normatus 226
(deleted)
(×) (5) (4) (×)
Hyperici herba ●●●● 26/10/2006
Hyperici herba 1438 × × × 2
NIS
2 ×
Hyperici oleum ●● Hyperici herba 1438 (×) (×) (×) ( 2 )
(NIS)
(2) (×)
Imperatoria ostruthium
rhizoma
○
Iridis rhizoma ● × (×)
Iris germanica rhizoma ●
Juglandis folium ● M
AESGP (09/10)
10/01/2008 Juglandis folium 2946 (in prep.) × × 2 (×)
Juniperi aetheroleum 17/09/2009 Juniperi aetheroleum 1832 (×) (×) (×) (3)
Juniperi pseudo-fructus ●○ 06/03/2008 Juniperi galbulus 1532
Juniperi aetheroleum 1832
× × × 3
Juniperus communis
summitates7
○ FR (07/13) 28/01/2014 Juniperi galbulus 1532
Juniperi aetheroleum 1832
(×) (×) × (3)
Lavandulae
aetheroleum
AESGP (10/08) 15/01/2009 Lavandulae aetheroleum 1338 × (×) (×) 3
Lavandulae flos 15/01/2009 Lavandulae flos 1534 × × × 3
6 November 2012: cancellation of assessment work 7 July 2015: cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 13/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Leonuri cardiacae
herba
Company
(08/09)
17/09/2009 Leonuri cardiacae herba 1833
Leonuri herba 2785 (in prep.)
× NIS (×)
Levistici radix ● H
AESGP (09/10)
10/01/2008 Levistici radix 1233 ×
Lichen islandicus ●○ L
AESGP (09/10)
23/11/2005 Lichen islandicus 1439 × × 4
Lini semen ●● 27/01/2005 Lini semen 95
Lini oleum virginale 1908 (deleted)
× × × 1 ×
Liquiritiae radix ●○ 03/07/2008 Liquiritiae radix 277
Liquiritiae radix praeparata 2861
(deleted)
× × × 1
NIS
1 ×
Lupuli flos ●●● 23/11/2005 Lupuli flos 1222 × × × 3
Lysimachia nummularia
herba
○ (×)
Malvae sylvestris flos PL (09/15) 29/09/2015 Malvae sylvestris flos 1541 × × × (×)
Malvae folium AT (09/15) 29/09/2015 Malvae folium 2391 (×) × × (×)
Marrubii herba L
AESGP (09/10)
07/09/2007 Marrubii herba 1835 × × ×
Mate folium ● 07/09/2007 Mate folium 2678 (in prep.) × ×
Matricariae
aetheroleum
07/09/2007 Matricarieae aetheroleum 1836 (×) (×) (×) (1)
Matricariae flos ●●●● 07/09/2007 Matricariae flos 404 × × × 1
NIS
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 14/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Melaleucae alternifoliae
aetheroleum
○ H
AESGP (09/10)
06/11/2008 Melaleucae aetheroleum 1837 × 2
Meliloti herba ●● 23/11/2005 Meliloti herba 2120 × × ×
Melissae folium ●●● 23/11/2005 Melissae folium 1447 × × × 2
NIS
Menthae piperitae
aetheroleum
●●● 23/11/2005 Menthae piperitae aetheroleum 405
Menthae arvensis aetheroleum partim
mentholum depletum 1838
× × (×) 2
NIS
(×)
Menthae piperitae
folium
●●● 23/11/2005 Menthae piperitae folium 406
Menthae arvensis aetheroleum partim
mentholum depletum 1838
× × × 2
NIS
(×)
Mercurialis perennis
planta tota
○
Millefolii flos ○ 10/01/2008 Millefolii herba 1382 (×) × (×) ( 4 )
(NIS)
(5) (×)
Millefolii herba ● 10/01/2008 Millefolii herba 1382 × × × 4
NIS
(5) (×)
Myrrha
(Commiphora molmol)
○ 06/10/2008 Myrrha 1349 × × × 3 (1) (3) ×
Myrtilli folium8 M
AESGP (09/10)
16/07/2009 Myrtilli fructus siccus 1588
Myrtilli fructus recens 1602
(×) × × (4)
Myrtilli fructus siccus ● H
AESGP (09/10)
10/01/2008 Myrtilli fructus siccus 1588 × × × 4
8 November 2014: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 15/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Myrtilli fructus recens ● H
AESGP (09/10)
01/07/2014 Myrtilli fructus recens 1602 × (×) × 4
Ocimi sancti folium ○ AYUSH (08/08) 2 2
(4)
2 (5)
Oenotherae biennis
oleum
●● 06/11/2008 Oenotherae oleum raffinatum 2104 2
Oleae folium 31/10/2008 Oleae folium 1878 × ×
Ononidis radix ○ 24/01/2012 Ononidis radix 1879 × × ×
Onopordon acanthium
flos
●●
Origani dictamni herba 12/07/2011 (Origani herba 1880) ×
Origanum majoranae
fructus
○ (Origani herba 1880) × (×)
Origanum majoranae
herba
○ AESGP (07/13) 28/01/2014 (Origani herba 1880) × ×
Orthosiphonis folium ●●● 10/01/2008 Orthosiphonis folium 1229 × × ×
Paeoniae radix ○ AESGP (07/13) 28/01/2014 Paeoniae radix alba 2424
Paeoniae radix rubra 2425
× 1 ×
Passiflorae herba ●●● 23/11/2005 Passiflorae herba 1459 × × × 3
Paulliniae semen
(=Guaranae semen)
EDQM (03/11) 31/03/2011 Guaranae semen 2669 (in prep.) ×
Pelargonii radix L
AESGP (09/10)
16/07/2009 Pelargonii radix 2264
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 16/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Phaseoli fructus (sine
semine)
● 13/09/2011 Phaseoli fructus (sine semine) 2952
(in prep.)
× 3
Pilosellae herba cum
flore
● 22/11/2011 Hieracii pilosellae herba cum radice
2822 (in prep.)
×
Piperis methystici
rhizome
● DE (05/15) 05/05/2015 × × 2
Piperis nigri fructus ● Piperis fructus 2477
Piperis longi fructus 2453
3 8 ×
Pistacia lentiscus,
resinum (Mastix)
(07/13) 28/01/2014 Mastix 1876 5
Plantaginis lanceolatae
folium
● 07/09/2007 Plantaginis lanceolatae folium 1884 × (×) × 6 (×)
Plantaginis ovatae
semen
●●●○ 23/03/2005 Plantaginis ovatae semen 1333 × × × 1
(3)
(×)
Plantaginis ovatae
seminis tegumentum
●●● 23/03/2005 Plantaginis ovatae seminis
tegumentum 1334
× × × 3
(1)
(×)
Platycodi radix ○ Platycodonis radix 2660 (in prep.) 1 ×
Polygalae radix9
(= Senegae radix)
●○○ Polygalae radix 202 × × × 2 ×
Polygoni avicularis
herba
PL (07/13) 28/01/2014 Polygoni avicularis herba 1885 × × NIS ×
Polypodii rhizoma ● 08/03/2007 Polypodii rhizoma 2953 (in prep.)
9 September 2007: cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 17/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Primulae flos ●● 13/07/2006 Primulae flos 2540 (in prep.) (×) × ×
Primulae radix ●●● 23/11/2005 Primulae radix 1364 × × ×
Pruni africani cortex ○ 12/07/2011 Pruni africanae cortex 1886 × 2
Pruni spinosae flos10 M
AESGP (09/10)
×
Pruni spinosae fructus ●● ×
Pruni spinosae
summitates7
● M
AESGP (09/10)
(×)
Psyllii semen ●●○ 23/03/2005 Psyllii semen 858 × × ×
Quercus cortex ○ 10/01/2008 Quercus cortex 1887 × (4)
Rauwolfiae radix ○○ × 1 5 8
Resina laricis
(see Terebinthinae
laricina)
○
Rhamni purshianae
cortex
●●○ 23/11/2005 Rhamni purshianae cortex 105 × × × 2
Rhei radix ●●○○ 23/11/2005 Rhei radix 291 × × × 1 ×
Rhodiolae roseae
rhizoma et radix
H
AESGP (09/10)
16/07/2009 Rhodiolae roseae rhizoma et radix
2893 (in prep.)
(×)
Ribis nigri folium ●○ 23/11/2005 Ribis nigri folium 2528 × ×
Ricini oleum PL (07/13) 28/01/2014 Ricini oleum virginale 0051
Ricini oleum raffinatum 2367
Ricini oleum hydrogenatum 1497
× 4 (1)
(3)
×
10 March 2012: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 18/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Rosae aetheroleum11 Rosae aetheroleum 3006 (in prep.) (×) × (3) (×)
Rosae flos 12/07/2011 Rosae flos 2949 (in prep.) × × 3 (×)
Rosmarini aetheroleum 15/01/2009 Rosmarini aetheroleum 1846 (×) (×) (×) 4
Rosmarini folium ●○ 07/09/2007 Rosmarini folium 1560 × × × 4
Rubi idaei folium 13/09/2011 Rubi idaei folium 2950 (in prep.) × (×)
Rusci aculeati rhizoma ●● 13/07/2006 Rusci rhizoma 1847 × × ×
Sabalis serrulatae
fructus (Serenoae
repentis fructus)
●●● L
AESGP (09/10)
07/09/2007 Sabalis serrulatae fructus 1848 × × 2
Saccharomyces
cerevisiae/
S. boulardii
DE (07/13) 28/01/2014 ×
Salix sp. cortex ●○ 23/11/2005 Salicis cortex 1583 × × × 4 (6)
Salix sp. folium ● Salicis cortex 1583 (×) (×) (×) (4) 6
Salviae officinalis
aetheroleum
17/09/2009 Salviae officinalis aetheroleum 2860
(in prep.)
Salviae lavandulifoliae aetheroleum
1849
Salviae sclareae aetheroleum 1850
(×) (×) (×) (NIS)
Salviae officinalis
folium
●●●● 08/03/2007 Salviae officinalis folium 1370 × × × NIS
Salviae trilobae folium ● (07/13) 28/01/2014 Salviae trilobae folium 1561 ×
11 March 2013: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 19/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Sambuci flos ●●● IVAA (05/07) 08/03/2007 Sambuci flos 1217 × × × 2
Sambuci fructus 13/09/2011 Sambuci flos 1217 (×) (×) (×) (2)
Scolopendrium
officinale folium
● ×
Sennae folium ●●●● 31/05/2005 Sennae folium 206 × × × 1
NIS
1 1 ×
Sennae fructus ●●●● 31/05/2005 Sennae fructus angustifoliae 208
Sennae fructus acutifoliae 207
×
×
× × 1
(NIS)
(1) 1 (×)
Sideritis herba (07/13) 28/01/2014
Silybi mariani fructus
(Cardui mariae fructus)
●●● M
AESGP (09/10)
11/03/2010 Silybi mariani fructus 1860 × × 2 2 ×
Sisymbrii officinalis
herba (Erysimi
officinalis herba)
H
AESGP (09/10)
27/01/2011 Sisymbrii officinalis herba 2942
(in prep.)
×
Solani dulcamarae
stipites
○ L
AESGP (09/10)
06/03/2008 Solani dulcamarae stipites 2944
(in prep.)
×
Solidaginis virgaureae
herba
●● 23/11/2005 Solidaginis virgaureae herba 1893
Solidaginis herba 1892
× × × (×)
Species amarae AT/DE (11/16) 29/01/2017
Species digestivae or
Species stomachicae
AT/DE (11/16) 29/01/2017
Species diureticae AT (11/15) 24/11/2015
Species sedativae AT/DE (11/16) 29/01/2017
Storax/ Benzoe tincture ● Benzoe sumatranus 1814
Benzoe tonkinensis 2158
×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 20/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Symphyti radix ●● 08/05/2008 × × ×
Tanaceti parthenii
herba
●● 08/05/2008 Tanaceti parthenii herba 1516 × × 2
Taraxaci folium ○ 06/03/2008 Taraxaci officinalis herba cum radice
1851
Taraxaci officinalis radix 1852
× (×) × ( 3 )
(NIS)
(×)
Taraxaci radix cum
herba
(= Taraxacum
officinale planta tota)
●○ 07/09/2007 Taraxaci officinalis herba cum radice
1851
Taraxaci officinalis radix 1852
(×) × (×) 3
NIS
(×)
Terebinthinae laricina12
(Resina laricis)
● Terebinthinae aetheroleum 1627 ×
Thymi aetheroleum 07/09/2007 Thymi typo thymolo aetheroleum
1374
(×) (×) (×) ( 1 )
(NIS)
Thymi herba ●●●● 23/11/2005 Thymi herba 865 × × × 1
NIS
Thymi herba/Primulae
radix fixed combination
07/09/2007 Thymi herba 865
Primulae radix 1364
×
Tiliae flos H
AESGP (09/10)
11/03/2010 Tiliae flos 957 × × NIS
12 May 2010: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 21/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Tiliae tomentosae flos L
AESGP (09/10)
11/03/2010 Tiliae flos 957 × (×) (NIS)
Tormentillae rhizoma ● 03/07/2008 Tormentillae rhizoma 1478 × × ×
Trigonellae foenugraeci
semen
(Foenugraeci semen )
●○ 10/01/2008 Trigonellae foenugraeci semen 1323 × × × 3 2 ×
Uncariae tomentosae
cortex
16/07/2010 Uncariae tomentosa cortex 2530
(in prep.)
3
Urticae dioica flos ○ Urticae folium 1897
Urticae radix 2538
(×) (×) (×) ( 2 )
(NIS)
Urticae folium ●● 23/11/2005 Urticae folium 1897 × × × ( 2 )
(NIS)
Urticae herba ●●●● 23/11/2005 Urticae folium 1897
Urticae radix 2538
× × × ( 2 )
(NIS)
Urticae radix ●●●● 23/11/2005 Urticae radix 2538 × × × 2
NIS
Uvae ursi folium ●●● 23/11/2005 Uvae ursi folium 1054 × × × 2
Vaccinii macrocarpi
fructus
Company
(12/14)
29/09/2015 × (×) (×) 4
Valerianae aetheroleum ●●●●○ 27/01/2005 Valerianae radix 453
Valerianae radix minutata 2526
(×) (×) × (1) (1)
Valerianae radix ●●●●○ 27/01/2005 Valerianae radix 453
Valerianae radix minutata 2526
× × × 1 (1)
Valerianae radix/ 31/10/2007 Valerianae radix 453 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 22/22
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after 2005 by
IPs/NCA (date)
Added to HMPC
Priority list
Ph. Eur. related monographs (Status June 2015)
ESCOP German Comm.
E
French Avis a. fabr.
WHO Indian Ph. Ch.
a b c
Lupuli flos
fixed combination
Lupuli flos 1222
Verbasci flos ● 08/03/2007 Verbasci flos 1853 × × ×
Violae tricoloris herba ● 10/01/2008 Violae herba cum flore 1855 (×) × × (×)
Visci albi herba ● 15/01/2009 Visci herba 1900 (deleted) × (×)
Vitis viniferae folium ●●● 31/10/2008 Vitis viniferae folium rubrum 2667
(in prep.)
× × (3)
Withaniae somniferae
radix
AYUSH (08/08) 12/07/2011 Withaniae somniferae radix 2746
(in prep.)
4 1
Zingiberis rhizoma ●●●● 23/11/2005 Zingiberis rhizoma 1522 × × × 1 1
(2)
8 ×