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Monographs - HMPC Escop Who Comm e 2011 Jul 26

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26 July 2011 EMA/HMPC/494079/2007

Inventory of herbal substances for assessment


(Column A) Working term for Community herbal monograph/Community list entries Highlighted herbal substances in grey are currently on the priority list (Column B) HMPC Total priority after survey among interested parties 2005 (AEFMUTA, AESGP, EFCAM, ESCOP, GA, IVAA, PSE): mentions with high, medium or not specified priority mentions with low priority (Column C) Priority request by interested parties at later stage: Abbreviation IP month/year H=High, M=Medium, L=Low (Column D) Current status of HMPC assessment: R: Rapporteur assigned, C: ongoing call for scientific data, D: Draft under discussion, P: Draft published, PF: Assessment close to finalisation (pre-final), F: Final opinion adopted (Column E) Related monographs in Ph. Eur. and current status: Specified monograph term, consideration of deviating species, Latin terms, or plant parts used, but no consideration of homeopathic monographs or pure isolated substances 1380/5(21.2)(6.2) = monograph number/state of work (Pharmeuropa No.) (Ph. Eur. supplement No.) 0 the monograph has been authorised but work has not started yet , 1 work has started , 2 authorised for publication in Pharmeuropa (see Pharmeuropa number) , 3 submitted for adoption to the Ph. Eur. Commission , 4 adopted , 5 about to be published or published

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7150 E-mail info@ema.europa.eu Website www.ema.europa.eu European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

An agency of the European Union

(Column F) ESCOP monographs: published monographs (2nd edition including supplement 2009) (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 lAgence No 3, Les mdicaments base de plantes 1998 (Column I) WHO monographs: 1 published in Volume 1 (1999), 2 published in Volume 2 (2002), 3 published in Volume 3 (2007), 4 published in Volume 4 (2009) (Column K) Indian monographs: * monograph in the Ayurvedic Pharmacopoeia of India, first edit. 2001, Part 1 Vol. 1 (**Vol. 2, *** Vol. 3, **** Vol. 4) monograph in the Database on medicinal plants used in Ayurveda, Central council for research in Ayurveda & Siddha. Vol. 1 2000, (Vol. 2 2001) monograph in the Quality Standards of Indian medicinal plants, Indian Council of Medical Research 2003. Vol. 1 ( Vol. 2, Vol. 3) (Column L) Chinese monographs: monograph in Chinese Pharmacopoeia (PPRC, Vol. 1 Traditional Chinese Materia Medica, Engl. edit. 2000), related species not considered e.g. Agrimonia pilosa instead of Agrimonia eupatoria or Aesculus chinense instead of Aesculus hippocastanum

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 2/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Absinthii herba 1380/5 (21.2) (7.1) Acori calami rhizoma 2456/2 (22.1) Acori tatarinowii rhizoma 2457/2 (22.1)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Absinthii herba Acori calami rhizoma

**

Adhatodae vasicae folium Agni casti fructus

C F

Adhatodae vasicae folium 2738/0 Agni casti fructus 2147/2 (23.3)(6.2) Agni casti fructus extractum siccum) 2309/2 (23.3)

*/****

Agrimoniae herba Agropyri repentis rhizoma Allii cepae bulbus Allii sativi bulbus Aloe

M (AESGP 09/10) M (AESGP 09/10) M (AESGP 09/10) H (AESGP 09/10)

R PF P C F

Agrimoniae herba 1587/5 (21.2)(7.0)

Allii sativi bulbi pulvis 1216/5 (6.0) Aloe barbadensis 257/5 (6.0) Aloe capensis 258/5 (6.0) Aloes extractum siccum normatum 259/5 (6.2)

1 1 1

*** *

Aloe vera gel

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 3/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Althaea folium 1856/5 (20.2) (7.3) Althaeae radix 1126/5 (20.2) (7.3)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Althaeae radix

Andrographidis herba Andrographidis paniculatae folium Angelicae sinensis radix

M (AESGP 09/10) R

Andrographis herba 2712/1

Angelicae radix 1857/2 (22.4) (7.0) Angelicae dahuricae radix 2556/5 (22.2)(7.3) Angelicae pubescentis radix 2557/5 (22.2)(7.3) Angelicae sinensis radix 2558/3 (22.2)

Anisi aetheroleum Anisi fructus Arctii folium (Bardanae folium) Arctii radix (Lappa major radix; Bardanae radix) Arnicae flos M (AESGP 09/10)

C C See footnote 1 F

Anisi aetherolum 804/5 (7.0) Anisi fructus 262/5 (20.4)(7.3)

3 3

Arnicae flos 1391/0 (7.3) (18.3)

November 2009: no monograph on Arctii folium will be established.


Page 4/21

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011)

E Ph. Eur. related monographs and status (June2011) Arnicae tinctura 1809/0 (6.3)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Arnica montana planta tota Aspidium filix-mas folium Astragali radix

Astragali membranacei (mongholici) radix 2435/5 (19.3) (7.0) 1

Avenae fructus Avenae herba Bacopae monnierii herba Balsamum peruvianum

F F

Avenae sativae seminis pulvis 2539/1 Avenae herba 2618/1 Balsamum peruvianum 754/5 (6.2) Balsamum tolutanum 1596/5 (6.0)

**

Betulae folium Boldi folium

F F

Betulae folium 1174/2 (6.2) (23.1) Boldi folium 1396/5 (6.0) (18.2) Boldi folii extractum siccum 1816/5 (6.1) (18.3)

Bruceae fructus Bryophyllum folium = Kalanchoe pinnata folium Bupleuri radix Bursae pastoris herba

F Bupleuri radix 2562/1

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 5/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011)

E Ph. Eur. related monographs and status (June2011)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Calendulae herba Calendulae flos Camelliae sinensis non fermentata folia Capsici fructus

EDQM (03/11) M (AESGP 09/10) C F C Calendulae flos 1297/5 (18.1) (7.0) Camelliae sinensis non fermentata folia 2668/0 Capsici fructus 1859/5 (18.4) (7.0) Capsici acris extractum spissum normatum 2529/2 (23.1) Capsici oleoresina raffinata et quantificata 2336/2 (23.1) (6.0) Capsici tinctura normata 2337/5 (17.1) (6.0)

x x 2

Carvi aetheroleum Carvi fructus Caryophylli aetheroleum Caryophylli flos* Centaurii herba Centellae folium

M (AESGP 09/10) H (AESGP 09/10)

R R PF

Carvi aetherolum 1817/5 (6.0) Carvi fructus 1080/5 (6.0) Caryophylli floris aetheroleum 1091/5 (6.0) Caryophylli flos 376/5 (6.0) Centaurii herba 1301/5 (16.4) (6.0) *** 2 2 * * *

L (AESGP 09/10)

P F

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 6/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Centellae asiaticae herba 1498/1 (6.0) Chamomillae romanae flos 380/1 (6.0) Chelidonii herba 1861/3 (22.3) (6.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Centellae asiaticae herba Chamomillae romanae flos Chelidonii herba* Chelidonium majus rhizoma Cichorii intybi planta tota Cichorium planta tota Cichorii intybi folium Cichorii intybi radix Cimicifugae racemosae rhizoma Cinnamomi aetheroleum
2

H (AESGP 09/10)

()

***

PF PF

D D

()

x Cimicifugae rhizoma 2069/2 (22.3) Cinnamomi zeylanicii corticis aetheroleum 1501/0 (7.1) Cinnamomi cortex 387/0 (21.3) (7.1) Cinnamomi corticis tinctura 1819/0 (6.0) Cinnamomi zeylanici folii aetheroleum 1608/0 (7.0) 2 1 *

F F

Cinnamomi cortex

Cinnamomi cortex 387/0 (21.3) (7.1)

Public statement
2

January 2010: Rapporteur deemed establishment of monograph not necessary.


Page 7/21

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011)

E Ph. Eur. related monographs and status (June2011) Cinnamomi zeylanicii corticis aetheroleum 1501/0 (7.1) Cinnamomi zeylanici folii aetheroleum 1608/0 (7.0) Cinnamomi corticis tinctura 1819/0 (6.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Cinnamomum camphora Citri bergami aetheroleum

M (AESGP 09/10) D Aurantii amari epicarpium et mesocarpium 1603/0 (19.1) (6.3) Aurantii amari flos 1810/5 (19.1) (7.3) Aurantii dulcis aetheroleum 1811/5 (6.0)

Citrus limon succus Colae semen Coptidis rhizoma Crataegi folium cum flore

AESGP 05/07 L (AESGP 09/10) R M (AESGP 09/10) Coptidis rhizoma 2715/0 Crataegi folium cum flore 1432/5 (6.6) Crataegi folii cum flore extractum fluidum quantificatum 1864/5 (16.1) (6.0) Crataegi folii cum flore extractum siccum 1865/5 (6.6) 1 2 P Colae semen 1504/5 (6.0) O

****

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 8/21

B Total priority HMPC 2005

C Later request by extern. IP AESGP 05/07 H (AESGP 09/10)

D Status HMPC (June 2011) R

E Ph. Eur. related monographs and status (June2011) Crataegi fructus 1220/2 (23.1) (6.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Crataegi fructus

Cucurbitae semen Curcurmae longae rhizoma Curcumae xanthorrhizae rhizoma Cyani flos Cydonia oblonga succus Cynarae folium

H (AESGP 09/10)

D F R Curcurmae longae rhizoma 2543/2 (23.2) Curcumae xanthorrhizae rhizoma 1441/5 (6.0)

1 *

PF

Cynarae folium 1866/5 (17.3) (7.3) Cynarae folii extractum siccum 2389/5 (19.1) (6.6)

Dryopteris filix mas Echinacea angustifolia planta tota Echinaceae angustifoliae radix Echinaceae pallidae radix Echinaceae purpureae herba

IVAA 05/07

P F F Echinaceae angustifoliae radix 1821/5 (6.0) Echinaceae pallidae radix 1822/5 (14.1) (6.0) Echinaceae purpureae herba 1823/5 (16.4) (6.0) Echinaceae purpureae herbae succus expressus 2282/1 1 1 1

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 9/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011)

E Ph. Eur. related monographs and status (June2011)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Echinacea purpurea planta tota Echinaceae purpureae radix Eleutherococci radix Emblicae officinalis fructus Ephedrae herba Equiseti herba Erysimi officinalis flos Eucalypti aetheroleum Eucalypti folium Euphrasiae herba* Filipendulae ulmariae flos Filipendulae ulmariae herba Foeniculi amari fructus

F F Echinaceae purpureae radix 1824/5 (16.4) (6.0) Eleutherococci radix 1419/0 (7.0)

1 2 * x

AESGP 05/06 H (AESGP 09/10) H (AESGP 09/10) H (AESGP 09/10) F F F F C C R F

Ephedrae herba 2451/5 (20.1) (6.7) Equiseti herba 1825/4 (22.3) (6.0)

Eucalypti aetheroleum 390/5 (20.4) (6.8) Eucalypti folium 1320/5 (18.2) (6.0)

2 2

Filipendulae ulmariae herba 1868/2 (23.3) (6.0) Foeniculi amari fructus 824/2 (23.3) (6.0)

3 *

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 10/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Foeniculi amari fructus aetherolum 1826/5 (6.0) Foeniculi amari herbae aetheroleum 2380/5 (19.4) (7.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Foeniculi amari fructus aetheroleum

Foeniculi dulcis fructus Fragaria vesca fructus

Foeniculi dulcis fructus 825/5 (21.3) (7.1)

Fragariae folium Frangulae cortex

H (AESGP 09/10)

R F Frangulae cortex 25/1 (21.2) (7.1) Frangulae corticis extractum siccum normatum 1214/0 (6.5)

Fraxini folium

L (AESGP 09/10)

Fraxini folium 1600/3 (21.3) (6.0) Fraxini cortex 2452/2 (23.3) Fucus vel Ascophyllum 1426/5 (6.0)

Fucus vesiculosus Fumariae herba Gentianae radix

M (AESGP 09/10) F PF

x x

x 3

Fumariae herba 1869/2 (22.3) (6.8) Gentianae radix 392/5 (6.0) Gentianae tinctura 1870/5 (6.0)

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 11/21

B Total priority HMPC 2005

C Later request by extern. IP L (AESGP 09/10)

D Status HMPC (June 2011) R

E Ph. Eur. related monographs and status (June2011) Ginkgonis folium 1828/5 (19.4) (7.0) Ginkgonis extractum siccum raffinatum et quantificatum 1827/5 (18.3) (6.1)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Ginkgo bilobae folium

Ginseng radix

L (AESGP 09/10)

Ginseng radix 1523/5 (6.0) Ginseng extractum siccum quantificatum 2356/3 (22.3) Notoginseng radix 2383/5 (17.4) (6.0)

Grindeliae herba Guaranae semen Hamamelidis cortex Hamamelidis folium Hamamelidis folium et cortex aut ramunculus destillatum Hamamelidis aqua Harpagophyti radix

L (AESGP 09/10) EDQM (03/11)

R R F F F Guaranae semen 2669/0 Hamamelidis cortex 2532/1 Hamamelidis folium 909/5 (18.3)(7.0) Hamamelidis folium et cortex, distillate 2533/1 F Harpagophyti radix 1095/5 (18.4) (7.0) Harpagophyti extractum siccum 1871/5 (18.1) (6.0)

x O

2 2 2

Hederae helicis folium Hieracium pilosella

Hederae folium 2148/2 (22.4) (7.0)

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 12/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) D

E Ph. Eur. related monographs and status (June2011) Hippocastani semen 1830/2 (21.2) Hippocastani seminis extractum siccum normatum 1829/2 (20.3)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Hippocastani cortex

Hippocastani semen

Hippocastani semen 1830/2 (21.2) Hippocastani seminis extractum siccum normatum 1829/2 (20.3)

Hyoscyami herba

Hyoscyami folium 225/5deleted Hyoscyami tincture 1873/5 deleted Hyoscyami pulvis normatus 226/5 deleted

()

Hyperici herba

Hyperici herba 1438/2 (23.3) (6.2) Hyperici herbae extractum siccum quantificatum 1874/2 (22.4) (6.3)

Hyperici oleum Imperatoria ostruthium rhizoma Iridis rhizoma Iris germanica rhizome

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 13/21

B Total priority HMPC 2005

C Later request by extern. IP M (AESGP 09/10)

D Status HMPC (June 2011) D F

E Ph. Eur. related monographs and status (June2011)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Juglandis folium Juniperi aetheroleum Juniperi pseudo-fructus

Iuniperi aetheroleum 1832/5 (7.0) Iuniperi pseudo-fructus 1532/5 (7.2) Iuniperi aetheroleum 1832/5 (7.0)

**

***

Juniperus communis summitates Lavandulae aetheroleum Lavandulae flos Leonuri cardiacae herba Levistici radix Lichen islandicus Lini semen

AESGP 10/08 P Company 08/09 H (AESGP 09/10) L (AESGP 09/10) C Lini semen 95/5 (21.3) (7.1) Lini oleum virginale 1908/deleted R D F P Lavandulae aetheroleum 1338/0 (20.4) (6.8) Lavandulae flos 1534/0 (21.3) (7.1) Leonuri cardiacae herba 1833/2 (23.1) (6.0) Levistici radix 1233/2 (22.4) (6.0) Lichen islandicus 1439/5 (6.8)

x 3

***

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 14/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) P

E Ph. Eur. related monographs and status (June2011) Liquiritiae radix 277/5 (20.1) (7.3) Liquiritiae extractum fluidum ethanolicum normatum 1536/5 (20.1) (7.3) Liquiritiae extractum siccum ad saporandum 2378/5 (22.1) (7.3)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Liquiritiae radix

Lupuli flos Lysimachia nummularia herba Marrubii herba Mate folium Matricariae aetheroleum Matricariae flos

L (AESGP 09/10)

F R F D

Lupuli flos 1222/5 (18.3) (7.0) Marrubii herba 1835/5 (6.0) Mate folium 2678/0 Matricarieae aetheroleum 1836/0 (6.0) Matricariae flos 404/5 (6.0) Matricariae extractum fluidum 1544/5 (6.2)

Melaleucae alternifoliae aetheroleum Meliloti herba Melissae folium

H (AESGP 09/10)

R F C

Melaleucae aetheroleum 1837/5 (7.0) Meliloti herba 2120/3 (22.3) (6.0) Melissae folium 1447/5 (19.3) (7.0) Melissae folii extractum siccum 2524/5 (20.1) (6.6)

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 15/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Menthae piperitae aetheroleum 405/2 (22.3) (6.0) Menthae arvensis aetheroleum partim mentholum depletum 1838/5 (6.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Menthae piperitae aetheroleum

Menthae piperitae folium

Menthae piperitae folium 406/5 (20.1) (7.0) Menthae piperitae folii extractum siccum 2382/5 (19.3) (6.4)

Mercurialis perennis planta tota Millefolii flos Millefolii herba Myrrha (Commiphora molmol) Myrtilli folium Myrtilli fructus siccus

M (AESGP 09/10) H (AESGP 09/10) R Myrtilli fructus siccum 1588/5 (6.0) Myrtilli fructus recens 1602/5 (6.1) Myrtilli fructus recentis extractum siccum raffinatum F F F R Millefolii herba 1382/5 (20.3) (7.3) Millefolii herba 1382/5 (20.3) (7.3) Myrrha 1349/5 (6.0) Myrrhae tinctura 1877/5 (6.0) 3 *

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 16/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011)

E Ph. Eur. related monographs and status (June2011) et normatum 2394/5 (18.4) (6.4)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Ocimi sancti folium Oenotherae biennis oleum Oleae folium

P P Oenotherae oleum raffinatum 2104/deleted Oleae folium 1878/5 (19.1) (6.3) Oleae folii extractum siccum 2313/5 (19.3) (6.4)

2 2

**/*** *

Ononidis radix Onopordon acanthium flos Origani dictamni herba Origanum majorana fructus Origanum majorana herba Orthosiphonis folium Paeoniae radix

C F

Ononidis radix 1879/5 (6.0)

(Origani herba 1880/5 (20.3) (7.0)) Orthosiphonis folium 1229/1 (19.2) (6.4) Paeoniae radix alba 2424/2 (23.1) Paeoniae radix rubra 2425/2 (23.1) 1

Passiflorae herba

Passiflorae herba 1459/5 (6.0) Passiflorae herbae extractum siccum 1882/5 (6.0)

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 17/21

B Total priority HMPC 2005

C Later request by extern. IP L (AESGP 09/10)

D Status HMPC (June 2011) P

E Ph. Eur. related monographs and status (June2011) Pelargonii radix 2264/5 (17.3) (6.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Pelargonii radix Phaseoli fructus (sine semine) Picrorhizae kurroae rhizoma Piperis methystici rhizoma Piperis nigri fructus

C Picrorhizae kurroae rhizoma et radix 2744/0 Piperis fructus 2477/2 (23.2) Piperis longi fructus 2453/2 (23.2) 2 4

*** **

**,*** 1 3 1 2

Plantaginis lanceolatae folium Plantaginis ovatae semen Plantaginis ovatae seminis tegumentum Platycodi radix Polygalae radix (= Senegae radix) Polypodii rhizoma Primulae flos Primulae radix Pruni africani cortex

PF C C

Plantaginis lanceolatae folium 1884/5 (18.1) (7.3) Plantaginis ovatae semen 1333/5 (6.0) Plantaginis ovatae seminis tegumentum 1334/5 (6.0) Platycodonis radix 2660/1

see footnote F C C C
3

Polygalae radix 202/1 (6.0)

Primulae flos 2540/1 Primulae radix 1364/2 (23.3) (6.0) Pruni africanae cortex 1886/5 (6.0)

3 September 2007: following AESGPs response on low priority level and absence of products on national markets, no monograph to be prepared until further notice
Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 18/21

B Total priority HMPC 2005

C Later request by extern. IP M (AESGP 09/10)

D Status HMPC (June 2011) R

E Ph. Eur. related monographs and status (June2011)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Pruni spinosae flos Pruni spinosae fructus Pruni spinosae summitates Psyllii semen Quercus cortex Rauwolfiae radix Resina laricis (see Terebinthinae laricina) Rhamni purshianae cortex

M (AESGP 09/10) F F Psyllii semen 858/5 (6.0) Quercus cortex 1887/5 (6.0) 1 **** R

Rhamni purshianae cortex 105/5 (21.2) (7.1) Rhamni purshianae extractum siccum normatum 1844/5 (17.1) (6.0)

Rhei radix

Rhei radix 291/2 (17.3) (6.0) Rhei extractum siccum normatum 1845/1

Rhodiolae roseae rhizoma Ribis nigri folium Rosae aetheroleum Rosae flos Rosmarini aetheroleum

H (AESGP 09/10)

P F C C F Rosmarini aetheroleum 1846/5 (6.0) Ribis nigri folium 2528/2 (23.3)

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 19/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F F

E Ph. Eur. related monographs and status (June2011) Rosmarini folium 1560/2 (23.1) (6.0) Rusci rhizoma 1847/5 (20.2) (7.0) Sabalis serrulatae fructus 1848/2 (22.4) (6.0) Sabalis serrulatae extractum 2579/2 (22.4)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Rosmarini folium Rusci aculeati rhizoma Sabalis serrulatae fructus


4

L (AESGP 09/10)

Salix sp. cortex

Salicis cortex 1583/2 (22.4) (6.8) Salicis corticis extractum siccum 2312/5 (18.1) (6.1)

Salix sp. folium Salviae officinalis aetheroleum

F Salviae officinalis folium 1370/1 (6.0) Salviae tincture 1889/5 (6.0) Salviae lavandulifoliae aetheroleum 1849/5 (18.4) (7.0)

Previously listed as Serenoae repentis fructus Public statement

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 20/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Salviae officinalis folium 1370/1 (6.0) Salviae tincture 1889/5 (6.0) Salviae lavandulifoliae aetheroleum 1849/5 (18.4) (7.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Salviae officinalis folium

Salviae trilobae folium Sambuci flos Scolopendrium officinale folium Sennae folium

F IVAA 05/07 F

Salviae trilobae folium 1561/5 (6.0) Sambuci flos 1217/2 (22.3) (6.0) Sennae folium 206/1 (6.0) Sennae folii extractum siccum normatum 1261/0 (6.3) 1 * O 2

Sennae fructus

Sennae fructus angustifoliae 208/1 (6.0) Sennae fructus acutifoliae 207/1 (6.0)

Silybi mariani fructus

M (AESGP 09/10)

Silybi mariani fructus 1860/5 (6.0) Silybi mariani extractum siccum raffinatum et normatum 2071/5 (17.1) (6.0)

Previously listed as Cardui mariae fructus


Page 21/21

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

B Total priority HMPC 2005

C Later request by extern. IP L (AESGP 09/10)

D Status HMPC (June 2011) R F

E Ph. Eur. related monographs and status (June2011)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Solani dulcamarae stipites Solidaginis virgaureae herba

Solidaginis virgaureae herba 1893/2 (22.4) (6.0) Solidaginis herba 1892/5 (6.0)

Storax/ Benzoe tincture

Benzoe sumatranus 1814/5 (17.1) (6.0) Benzoe tonkinensis 2158/0 (15.4) (6.0) Benzois sumantrani tinctura 1813/5 (16.3) (6.0) Benzois tonkinensis tinctura 2157/5 (16.3) (6.0)

Symphyti radix Tanaceti parthenii herba Taraxaci folium Taraxaci radix cum herba (= Taraxacum officinale planta tota) Terebinthinae laricina (see also Resina laricis)

P F F F Taraxaci officinalis herba cum radice 1851/5 (20.1) (6.6) Taraxaci officinalis radix 1852/5 (19.4) (7.0) Tanaceti parthenii herba 1516/5 (6.0)

()

() 3

See footnote 6

May 2010: following AESGPs response on low priority level and the presence of only one combination product and no single-ingredient product on national markets, no monograph to be prepared until further notice
Page 22/21

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F

E Ph. Eur. related monographs and status (June2011) Thymi typo thymolo aetheroleum 1374/5 (22.2) (7.3)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Thymi aetheroleum

Thymi herba

Thymi herba 865/1 (19.2) (6.4) Thymi extractum liquidum normatum 1894/1deleted

Thymi herba/Primulae radix fixed combination

Thymi herba 865/1 (19.2) (6.4) Primulae radix 1364/2 (23.3) (6.0)

Tiliae flos

H (AESGP 09/10)

Tiliae flos 957/0(6.0)

Tiliae tomentosae flos

L (AESGP 09/10)

Tormentillae rhizoma

Tormentillae rhizoma 1478/5 (6.8) Tormentillae tinctura 1895/5 (6.0)

Trigonellae foenugraeci semen


7

F R

Trigonellae foenugraeci semen 1323/5 (6.6) Uncariae tomentosa cortex 2530/1

**

Uncaria tomentosa cortex Urtica dioica flos

Previously listed as Foenugraeci semen


Page 23/21

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) F F PF F C

E Ph. Eur. related monographs and status (June2011) Urticae folium 1897/5 (21.1) (7.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Urticae folium Urticae herba Urticae radix Uvae ursi folium Valerianae radix

2 2 1 *

Urticae radix 2538/2 (23.2) Uvae ursi folium 1054/2 (23.3) (7.1) Valerianae radix 453/5 (20.2) (6.8) Valerianae radix minutata 2526/5 (20.2) (6.8) Valerianae tinctura 1899/5 (17.3) (6.8) Valerianae extractum hydroalcoholicum siccum 1898/5 (21.2) (7.1) Valerianae extractum aquosum siccum 2400/5 (19.2) (6.8)

Valerianae radix/Lupuli flos fixed combination Verbasci flos Violae tricoloris herba

Valerianae radix 453/5 (20.2) (6.8) Lupuli flos 1222/5 (18.3) (7.0)

F F

Verbasci flos 1853/5 (20.3) (7.0) Violae herba cum flore 1855/5 (6.0) O

Public statement
Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 24/21

B Total priority HMPC 2005

C Later request by extern. IP

D Status HMPC (June 2011) D F c

E Ph. Eur. related monographs and status (June2011) Visci herba 1900/deleted Vitis viniferae folium 2667/1 Withaniae somniferae radix 2746/0 Zingiberis rhizoma 1522/5 (18.4) (7.0)

F ESCOP

G German Comm. E

H French Avis aux fabr.

I WHO

K Indian

L Chinese

Visci albi herba Vitis viniferae folium Withaniae somniferae radix Zingiberis rhizoma

4 1 * ***

Inventory of herbal substances for assessment EMA/HMPC/494079/2007

Page 25/21

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