inventory of herbal substances for assessment herbal substances

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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 /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)

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500017724.pdf


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 ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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.)

× ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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

× × × ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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) ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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 × × ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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 (×)





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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

×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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 ×





IPs/NCA (date)

Added to HMPC

Priority list


ESCOP German Comm.

E


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 ×

inventory of herbal substances for assessment herbal substances

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