Monographs_hmpc Escop Who Comm e 2011 Jul 26

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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

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

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 2/21

(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 l’Agence No 3, Les médicaments à 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


A 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

Absinthii herba ●●● F Absinthii herba 1380/5 (21.2)

(7.1)

× × ×

Acori calami rhizoma ● Acori calami rhizoma 2456/2

(22.1)

Acori tatarinowii rhizoma

2457/2 (22.1)

**■ ×

Adhatodae vasicae folium C Adhatodae vasicae folium

2738/0

*/****

■

Agni casti fructus

●● F Agni casti fructus 2147/2

(23.3)(6.2)

Agni casti fructus extractum

siccum) 2309/2 (23.3)

× × ×

Agrimoniae herba ● M (AESGP

09/10)

R Agrimoniae herba 1587/5

(21.2)(7.0)

× × ×

Agropyri repentis rhizoma ● M (AESGP

09/10)

PF ×

Allii cepae bulbus ○ M (AESGP

09/10)

P × 1 □□□

Allii sativi bulbus ●●●● H (AESGP

09/10)

C Allii sativi bulbi pulvis 1216/5

(6.0)

× × × 1 ***□□□

Aloe ●●○ F Aloe barbadensis 257/5 (6.0)

Aloe capensis 258/5 (6.0)

Aloes extractum siccum

normatum 259/5 (6.2)

×

×

× × 1 *■ ×

Aloe vera gel

○ O × 1


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Althaeae radix ●●●● F Althaea folium 1856/5 (20.2)

(7.3)

Althaeae radix 1126/5 (20.2)

(7.3)

× × × 2

Andrographidis herba ○ Andrographis herba 2712/1 2 ×

Andrographidis paniculatae

folium

M (AESGP

09/10)

R

Angelicae sinensis radix ●○ 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)

× 2 ×

Anisi aetheroleum C Anisi aetherolum 804/5 (7.0) 3

Anisi fructus ●●●●● C Anisi fructus 262/5

(20.4)(7.3)

× × × 3

Arctii folium

(Bardanae folium)

● See

footnote1

×

Arctii radix

(Lappa major radix; Bardanae

radix)

● F × ×

Arnicae flos ●●●● M (AESGP

09/10)

R Arnicae flos 1391/0 (7.3)

(18.3)

× × × 3

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


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Arnicae tinctura 1809/0 (6.3)

Arnica montana planta tota ●●

Aspidium filix-mas folium

●

Astragali radix ○ Astragali membranacei

(mongholici) radix 2435/5

(19.3) (7.0)

1 ×

Avenae fructus F Avenae sativae seminis pulvis

2539/1

× ×

Avenae herba ●○ F Avenae herba 2618/1 ×

Bacopae monnierii herba **■

Balsamum peruvianum ○ Balsamum peruvianum 754/5

(6.2)

Balsamum tolutanum 1596/5

(6.0)

×

Betulae folium ●●●●●● F Betulae folium 1174/2 (6.2)

(23.1)

× × ×

Boldi folium ●● F Boldi folium 1396/5 (6.0)

(18.2)

Boldi folii extractum siccum

1816/5 (6.1) (18.3)

× × ×

Bruceae fructus ○ 1 ×

Bryophyllum folium =

Kalanchoe pinnata folium

●●

Bupleuri radix ○ Bupleuri radix 2562/1 1 ×

Bursae pastoris herba ○ F × ×


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Calendulae herba ●● ×

Calendulae flos ●●●○ F Calendulae flos 1297/5 (18.1)

(7.0)

× × × 2

Camelliae sinensis non

fermentata folia

EDQM

(03/11)

C Camelliae sinensis non

fermentata folia 2668/0

x

Capsici fructus M (AESGP

09/10)

C 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

Carvi aetheroleum ○ M (AESGP

09/10)

R Carvi aetherolum 1817/5 (6.0)

Carvi fructus ●●●● H (AESGP

09/10)

R Carvi fructus 1080/5 (6.0) × × × *

Caryophylli aetheroleum ○ PF Caryophylli floris aetheroleum

1091/5 (6.0)

× × 2 * ×

Caryophylli flos* ○ L (AESGP

09/10)

P Caryophylli flos 376/5 (6.0) × × 2 * ×

Centaurii herba ●●○○ F Centaurii herba 1301/5 (16.4)

(6.0)

× × ×

Centellae folium ● ***■■


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Centellae asiaticae herba ○ F Centellae asiaticae herba

1498/1 (6.0)

× (×) 1 ***■■

Chamomillae romanae flos ● H (AESGP

09/10)

PF Chamomillae romanae flos

380/1 (6.0)

× ×

Chelidonii herba* ○ PF Chelidonii herba 1861/3

(22.3) (6.0)

× ×

Chelidonium majus rhizoma ●●

Cichorii intybi planta tota2

Cichorium planta tota

●

○

× (×) ×

Cichorii intybi folium D

Cichorii intybi radix

D x

Cimicifugae racemosae

rhizoma

●●● F Cimicifugae rhizoma 2069/2

(22.3)

× × 2

Cinnamomi aetheroleum F 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


× × × 1 *□ ×

Cinnamomi cortex ○ F Cinnamomi cortex 387/0

(21.3) (7.1)

× × × 1 *□ ×

Public statement

2 January 2010: Rapporteur deemed establishment of monograph not necessary.


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Cinnamomi zeylanicii corticis


Cinnamomi zeylanici folii


Cinnamomi corticis tinctura

1819/0 (6.0)

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 ● M (AESGP

09/10)

P Colae semen 1504/5 (6.0) O × ×

Coptidis rhizoma ○ Coptidis rhizoma 2715/0 1 ×

Crataegi folium cum flore ●●● AESGP

05/07

L (AESGP

09/10)

R 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)

× × × 2


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Crataegi fructus ●● AESGP

05/07

H (AESGP

09/10)

R Crataegi fructus 1220/2 (23.1)

(6.0)

× × ×

Cucurbitae semen ● D ×

Curcurmae longae rhizoma ●●● F Curcurmae longae rhizoma

2543/2 (23.2)

× × × 1 *■ ×

Curcumae xanthorrhizae

rhizoma

●●● H (AESGP

09/10)

R Curcumae xanthorrhizae

rhizoma 1441/5 (6.0)

× × × □

Cyani flos ● ×

Cydonia oblonga succus ●●

Cynarae folium ●●● PF Cynarae folium 1866/5 (17.3)

(7.3)

Cynarae folii extractum siccum

2389/5 (19.1) (6.6)

× × ×

Dryopteris filix mas IVAA

05/07

×

Echinacea angustifolia planta

tota

●● ×

Echinaceae angustifoliae radix ●● P Echinaceae angustifoliae radix

1821/5 (6.0)

× × 1

Echinaceae pallidae radix ●● F Echinaceae pallidae radix

1822/5 (14.1) (6.0)

× × 1

Echinaceae purpureae herba ●●● F Echinaceae purpureae herba

1823/5 (16.4) (6.0)

Echinaceae purpureae herbae

succus expressus 2282/1

× × 1


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


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 ● F Echinaceae purpureae radix

1824/5 (16.4) (6.0)

× × 1

Eleutherococci radix ●● F Eleutherococci radix 1419/0

(7.0)

× × × 2

Emblicae officinalis fructus

* x

Ephedrae herba ○ Ephedrae herba 2451/5 (20.1)

(6.7)

× 1 ×

Equiseti herba ●●○ AESGP

05/06

F Equiseti herba 1825/4 (22.3)

(6.0)

× × ×

Erysimi officinalis flos H (AESGP

09/10)

R x

Eucalypti aetheroleum ● H (AESGP

09/10)

C Eucalypti aetheroleum 390/5

(20.4) (6.8)

× × 2

Eucalypti folium ●○ H (AESGP

09/10)

C Eucalypti folium 1320/5 (18.2)

(6.0)

× × 2 ×

Euphrasiae herba* ● F ×

Filipendulae ulmariae flos ○ F ×

Filipendulae ulmariae herba ○ F Filipendulae ulmariae herba

1868/2 (23.3) (6.0)

× ×

Foeniculi amari fructus ●●●● F Foeniculi amari fructus 824/2

(23.3) (6.0)

× × × 3 * ×


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Foeniculi amari fructus

aetheroleum

F Foeniculi amari fructus

aetherolum 1826/5 (6.0)

Foeniculi amari herbae


(7.0)

×

Foeniculi dulcis fructus F Foeniculi dulcis fructus 825/5

(21.3) (7.1)

× × × * ×

Fragaria vesca fructus

○

Fragariae folium ●●● H (AESGP

09/10)

R ×

Frangulae cortex ●●○ F Frangulae cortex 25/1 (21.2)

(7.1)

Frangulae corticis extractum

siccum normatum 1214/0

(6.5)

× × × 2

Fraxini folium ● L (AESGP

09/10)

P Fraxini folium 1600/3 (21.3)

(6.0)

Fraxini cortex 2452/2 (23.3)

× × ×

Fucus vesiculosus ● Fucus vel Ascophyllum 1426/5

(6.0)

× ×

Fumariae herba M (AESGP

09/10)

PF Fumariae herba 1869/2 (22.3)

(6.8)

x x x

Gentianae radix ●●● F Gentianae radix 392/5 (6.0)

Gentianae tinctura 1870/5

(6.0)

× × × 3


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Ginkgo bilobae folium ●●● L (AESGP

09/10)

R Ginkgonis folium 1828/5

(19.4) (7.0)

Ginkgonis extractum siccum

raffinatum et quantificatum

1827/5 (18.3) (6.1)

× × 1 ×

Ginseng radix ●●● L (AESGP

09/10)

R Ginseng radix 1523/5 (6.0)

Ginseng extractum siccum

quantificatum 2356/3 (22.3)

Notoginseng radix 2383/5

(17.4) (6.0)

× × × 1 ×

Grindeliae herba L (AESGP

09/10)

R x x x

Guaranae semen EDQM

(03/11)

R Guaranae semen 2669/0 O

Hamamelidis cortex ●○ F Hamamelidis cortex 2532/1 × × 2

Hamamelidis folium ●○ F Hamamelidis folium 909/5

(18.3)(7.0)

× × × 2

Hamamelidis folium et cortex

aut ramunculus destillatum

Hamamelidis aqua

●○ F Hamamelidis folium et cortex,

distillate 2533/1

× 2

Harpagophyti radix ●●●● F Harpagophyti radix 1095/5

(18.4) (7.0)

Harpagophyti extractum

siccum 1871/5 (18.1) (6.0)

× × × 3

Hederae helicis folium ●●●● F Hederae folium 2148/2 (22.4)

(7.0)

× × ×

Hieracium pilosella ● ×


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Hippocastani cortex ● D Hippocastani semen 1830/2

(21.2)

Hippocastani seminis

extractum siccum normatum

1829/2 (20.3)

× ×

Hippocastani semen ●●●● F Hippocastani semen 1830/2

(21.2)

Hippocastani seminis

extractum siccum normatum

1829/2 (20.3)

× × × 2

Hyoscyami herba ●● Hyoscyami folium

225/5deleted

Hyoscyami tincture 1873/5

deleted

Hyoscyami pulvis normatus

226/5 deleted

(×)

Hyperici herba ●●●● F Hyperici herba 1438/2 (23.3)

(6.2)

Hyperici herbae extractum

siccum quantificatum 1874/2

(22.4) (6.3)

× × × 2 □□

Hyperici oleum ●●

Imperatoria ostruthium

rhizoma

○

Iridis rhizoma ●

Iris germanica rhizome

●


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Juglandis folium ● M (AESGP

09/10)

D × × ** ×

Juniperi aetheroleum F Iuniperi aetheroleum 1832/5

(7.0)

Juniperi pseudo-fructus ●○ F Iuniperi pseudo-fructus

1532/5 (7.2)

Iuniperi aetheroleum 1832/5

(7.0)

× × × ***

Juniperus communis

summitates

○ x ***

Lavandulae aetheroleum AESGP

10/08

P Lavandulae aetheroleum

1338/0 (20.4) (6.8)

× 3

Lavandulae flos P Lavandulae flos 1534/0 (21.3)

(7.1)

× ×

Leonuri cardiacae herba Company

08/09

F Leonuri cardiacae herba

1833/2 (23.1) (6.0)

× ×

Levistici radix ● H (AESGP

09/10)

D Levistici radix 1233/2 (22.4)

(6.0)

×

Lichen islandicus ●○ L (AESGP

09/10)

R Lichen islandicus 1439/5 (6.8) × ×

Lini semen

●● C Lini semen 95/5 (21.3) (7.1)

Lini oleum virginale

1908/deleted

× × * ×


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Liquiritiae radix ●○ P 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)

× × × 1 * ×

Lupuli flos ●●● F Lupuli flos 1222/5 (18.3) (7.0) × × × 3

Lysimachia nummularia herba ○ ×

Marrubii herba L (AESGP

09/10)

R Marrubii herba 1835/5 (6.0) × ×

Mate folium ● F Mate folium 2678/0 × ×

Matricariae aetheroleum D Matricarieae aetheroleum

1836/0 (6.0)

Matricariae flos

●●●● D Matricariae flos 404/5 (6.0)

Matricariae extractum fluidum

1544/5 (6.2)

× × × 1

Melaleucae alternifoliae

aetheroleum

○ H (AESGP

09/10)

R Melaleucae aetheroleum

1837/5 (7.0)

× 2

Meliloti herba ●● F Meliloti herba 2120/3 (22.3)

(6.0)

× × ×

Melissae folium ●●● C Melissae folium 1447/5 (19.3)

(7.0)

Melissae folii extractum

siccum 2524/5 (20.1) (6.6)

× × × 2


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Menthae piperitae

aetheroleum

●●● F Menthae piperitae


(6.0)

Menthae arvensis aetheroleum

partim mentholum depletum

1838/5 (6.0)

× × 2 ×

Menthae piperitae folium ●●● F Menthae piperitae folium

406/5 (20.1) (7.0)

Menthae piperitae folii

extractum siccum 2382/5

(19.3) (6.4)

× × × 2 ×

Mercurialis perennis planta

tota

○

Millefolii flos ○ F Millefolii herba 1382/5 (20.3)

(7.3)

×

Millefolii herba ● F Millefolii herba 1382/5 (20.3)

(7.3)

× × ×

Myrrha (Commiphora

molmol)

○ F Myrrha 1349/5 (6.0)

Myrrhae tinctura 1877/5 (6.0)

× × × 3 *□□□

Myrtilli folium M (AESGP

09/10)

R ×

Myrtilli fructus siccus ● 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

× × ×


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

et normatum 2394/5 (18.4)

(6.4)

Ocimi sancti folium ○ 2 **/***

*■■

Oenotherae biennis oleum ●● P Oenotherae oleum raffinatum

2104/deleted

2

Oleae folium P Oleae folium 1878/5 (19.1)

(6.3)

Oleae folii extractum siccum

2313/5 (19.3) (6.4)

× ×

Ononidis radix ○ Ononidis radix 1879/5 (6.0) × × ×

Onopordon acanthium flos ●●

Origani dictamni herba C

Origanum majorana fructus ○ ×

Origanum majorana herba ○ (Origani herba 1880/5 (20.3)

(7.0))

× ×

Orthosiphonis folium ●●● F Orthosiphonis folium 1229/1

(19.2) (6.4)

× × ×

Paeoniae radix ○ Paeoniae radix alba 2424/2

(23.1)

Paeoniae radix rubra 2425/2

(23.1)

× 1 ×

Passiflorae herba ●●● C Passiflorae herba 1459/5 (6.0)

Passiflorae herbae extractum

siccum 1882/5 (6.0)

× × × 3


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Pelargonii radix L (AESGP

09/10)

P Pelargonii radix 2264/5 (17.3)

(6.0)

Phaseoli fructus (sine semine) ● × *** ×

Picrorhizae kurroae rhizoma C Picrorhizae kurroae rhizoma et

radix 2744/0

4 ** x

Piperis methystici rhizoma ● × 2

Piperis nigri fructus ● Piperis fructus 2477/2 (23.2)

Piperis longi fructus 2453/2

(23.2)

**,***

□

×

Plantaginis lanceolatae

folium

● PF Plantaginis lanceolatae folium

1884/5 (18.1) (7.3)

× × ×

Plantaginis ovatae semen ●●●○ C Plantaginis ovatae semen

1333/5 (6.0)

× × × 1

Plantaginis ovatae seminis

tegumentum

●●● C Plantaginis ovatae seminis

tegumentum 1334/5 (6.0)

× × × 3

Platycodi radix ○ Platycodonis radix 2660/1 1

Polygalae radix

(= Senegae radix)

●○○ see

footnote3

Polygalae radix 202/1 (6.0) × × × 2 ×

Polypodii rhizoma ● F

Primulae flos ●● C Primulae flos 2540/1 × ×

Primulae radix ●●● C Primulae radix 1364/2 (23.3)

(6.0)

× × ×

Pruni africani cortex ○ C Pruni africanae cortex 1886/5

(6.0)

× 2

3 September 2007: following AESGP’s response on low priority level and absence of products on national markets, no monograph to be prepared until further notice


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Pruni spinosae flos M (AESGP

09/10)

R

Pruni spinosae fructus ●● ×

Pruni spinosae summitates ● M (AESGP

09/10)

R ×

Psyllii semen ●●○ F Psyllii semen 858/5 (6.0) × × ×

Quercus cortex ○ F Quercus cortex 1887/5 (6.0) × ****

Rauwolfiae radix ○○ × 1

Resina laricis

(see Terebinthinae laricina)

○

Rhamni purshianae cortex ●●○ F Rhamni purshianae cortex

105/5 (21.2) (7.1)

Rhamni purshianae extractum

siccum normatum 1844/5

(17.1) (6.0)

× × × 2

Rhei radix ●●○○ F Rhei radix 291/2 (17.3) (6.0)

Rhei extractum siccum

normatum 1845/1

× × × 1 ×

Rhodiolae roseae rhizoma H (AESGP

09/10)

P ×

Ribis nigri folium ●○ F Ribis nigri folium 2528/2

(23.3)

× ×

Rosae aetheroleum C

Rosae flos C

Rosmarini aetheroleum F Rosmarini aetheroleum

1846/5 (6.0)


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Rosmarini folium ●○ F Rosmarini folium 1560/2

(23.1) (6.0)

× × ×

Rusci aculeati rhizoma ●● F Rusci rhizoma 1847/5 (20.2)

(7.0)

× × ×

Sabalis serrulatae fructus 4 ●●● L (AESGP

09/10)

R Sabalis serrulatae fructus

1848/2 (22.4) (6.0)

Sabalis serrulatae extractum

2579/2 (22.4)

× × 2

Salix sp. cortex ●○ F 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


(7.0)

4 Previously listed as ‘Serenoae repentis fructus’ Public statement


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Salviae officinalis folium ●●●● F Salviae officinalis folium

1370/1 (6.0)

Salviae tincture 1889/5 (6.0)

Salviae lavandulifoliae


(7.0)

× × ×

Salviae trilobae folium ● Salviae trilobae folium 1561/5

(6.0)

Sambuci flos ●●● IVAA

05/07

F Sambuci flos 1217/2 (22.3)

(6.0)

O × × 2

Scolopendrium officinale folium ●

Sennae folium ●●●● F Sennae folium 206/1 (6.0)

Sennae folii extractum siccum

normatum 1261/0 (6.3)

× × × 1 *□ ×

Sennae fructus ●●●● F Sennae fructus angustifoliae

208/1 (6.0)

Sennae fructus acutifoliae

207/1 (6.0)

× × × 1 *□ ×

Silybi mariani fructus5 ●●● M (AESGP

09/10)

R Silybi mariani fructus 1860/5

(6.0)

Silybi mariani extractum

siccum raffinatum et

normatum 2071/5 (17.1)

(6.0)

O × × 2

5 Previously listed as ‘Cardui mariae fructus’


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Solani dulcamarae stipites ○ L (AESGP

09/10)

R

Solidaginis virgaureae herba ●● F 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

●● P × × ×

Tanaceti parthenii herba ●● F Tanaceti parthenii herba

1516/5 (6.0)

× × 2

Taraxaci folium ○ F × × ×

Taraxaci radix cum herba

(= Taraxacum officinale planta

tota)

●○ F Taraxaci officinalis herba cum

radice 1851/5 (20.1) (6.6)

Taraxaci officinalis radix

1852/5 (19.4) (7.0)

(×) × (×)

3

Terebinthinae laricina

(see also Resina laricis)

● See

footnote6

×

6 May 2010: following AESGP’s 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


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Thymi aetheroleum F Thymi typo thymolo


(7.3)

Thymi herba ●●●● F Thymi herba 865/1 (19.2)

(6.4)

Thymi extractum liquidum

normatum 1894/1deleted

× × × 1

Thymi herba/Primulae radix

fixed combination

P Thymi herba 865/1 (19.2)

(6.4)

Primulae radix 1364/2 (23.3)

(6.0)

×

Tiliae flos H (AESGP

09/10)

D Tiliae flos 957/0(6.0) x ×

Tiliae tomentosae flos L (AESGP

09/10)

D

Tormentillae rhizoma ● F Tormentillae rhizoma 1478/5

(6.8)

Tormentillae tinctura 1895/5

(6.0)

× ×

Trigonellae foenugraeci

semen7

●○ F Trigonellae foenugraeci semen

1323/5 (6.6)

× × × 3 **

Uncaria tomentosa cortex R Uncariae tomentosa cortex

2530/1

Urtica dioica flos

○

7 Previously listed as ‘Foenugraeci semen’


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Urticae folium ●● F Urticae folium 1897/5 (21.1)

(7.0)

× × ×

Urticae herba ●●●● F × × ×

Urticae radix ●●●● PF Urticae radix 2538/2 (23.2) × × × 2

Uvae ursi folium ●●● F Uvae ursi folium 1054/2

(23.3) (7.1)

× × × 2

Valerianae radix ●●●●○ C 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)

× × × 1 *

Valerianae radix/Lupuli flos

fixed combination

F Valerianae radix 453/5 (20.2)

(6.8)

Lupuli flos 1222/5 (18.3) (7.0)

×

Verbasci flos ● F Verbasci flos 1853/5 (20.3)

(7.0)

× ×

Violae tricoloris herba ● F Violae herba cum flore 1855/5

(6.0)

O × ×

Public statement


A B

Total

priority

HMPC

2005

C

Later

request by

extern. IP

D

Status

HMPC

(June

2011)

E

Ph. Eur.


status (June2011)

F

ESCOP

G

German

Comm. E

H

French

Avis aux

fabr.

I

WHO

K

Indian

L

Chinese

Visci albi herba ● D Visci herba 1900/deleted ×

Vitis viniferae folium ●●● F Vitis viniferae folium 2667/1 × × ***

Withaniae somniferae radix c Withaniae somniferae radix

2746/0

4

Zingiberis rhizoma ●●●● P Zingiberis rhizoma 1522/5

(18.4) (7.0)

× × × 1 * ×

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