22 July 2014 EMA/HMPC/494079/2007

Inventory of herbal substances for assessment Last update: July 2014

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European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

Column A: Herbal substances (working term) proposed for Community herbal monograph/Community 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: Priority request by IPs or National Competent Authorities (NCAs) after 2005 Abbreviation IP or Member State NCA (month/year), H=High, M=Medium, L=Low priority Column D: Addition to the HMPC priority list for assessment (EMA/HMPC/278067/2006) Specified date (dd/mm/yyyy) Column E: Related monographs on quality in the European Pharmacopoeia: Specified monograph term and Ph. Eur. monograph number, (in prep.) = planned or in preparation Related monographs and list entries of other selected scientific or regulatory publications: Column F: ESCOP monographs published monographs (2nd ed. including suppl. 2009; indiv. monographs published online by Jul 2014) 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, ***** Vol. 5) 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, Vol. 8) Column L: Chinese monographs monograph in Chinese Pharmacopoeia (PPRC, Vol. 1 Traditional Chinese Materia Medica, 2010), 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

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Absinthii herba 23/11/2005 Absinthii herba 1380

Acori calami rhizoma Acori calami rhizoma 2456 (in prep.)

Acori tatarinowii rhizoma 2457 (in prep.)

**

Adhatodae vasicae

folium

AYUSH

08/2008

12/07/2011 Adhatodae vasicae folium 2738 (in prep.) */****

Agni casti fructus 07/09/2007 Agni casti fructus 2147

Agni casti fructus extractum siccum 2309

(in prep.)

Agrimoniae herba M (AESGP

09/10)

10/01/2008 Agrimoniae herba 1587

Agropyri repentis

rhizoma

M (AESGP

09/10)

10/01/2008

Allii cepae bulbus M (AESGP

09/10)

11/03/2010 1

Allii sativi bulbus H (AESGP

09/10)

23/11/2005 Allii sativi bulbi pulvis 1216 1 ***

Aloe 23/11/2005 Aloe barbadensis 257

Aloe capensis 258

Aloes extractum siccum normatum 259

1 *

Aloe vera gel 1

Althaeae radix 07/09/2006 Althaea folium 1856

Althaeae radix 1126

2 *****

Andrographidis herba Andrographis herba 2712 (in prep.) 2

Andrographidis

paniculatae folium

M (AESGP

09/10)

27/01/2011 2

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 3/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Angelicae sinensis radix 22/11/2011 Angelicae archangelicae radix 1857

Angelicae dahuricae radix 2556

Angelicae pubescentis radix 2557

Angelicae sinensis radix 2558

2

Anisi aetheroleum 23/11/2005 Anisi aetherolum 804 3

Anisi fructus 23/11/2005 Anisi fructus 262 3

Arctii folium

(Bardanae folium)

Arctii radix

(Lappa major radix;

Bardanae radix)

06/11/2008

Arnicae flos M (AESGP

09/10)

07/09/2007 Arnicae flos 1391

Arnicae tinctura 1809

3

Arnica montana planta

tota

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 13/07/2006 Avenae herba 2618 (in prep.)

Bacopae monnierii herba AYUSH

08/2008

Bacopa monnieri 2850 (in prep.) **

Balsamum peruvianum (AESGP

07/13)

28/01/2014 Balsamum peruvianum 754

Balsamum tolutanum 1596

Betulae folium 23/11/2005 Betulae folium 1174

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 4/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Boldi folium 23/11/2005 Boldi folium 1396

Boldi folii extractum siccum 1816

Bruceae fructus 1

Bryophyllum folium =

Kalanchoe pinnata

folium

Bupleuri radix Bupleuri radix 2562 (in prep.) 1

Bursae pastoris herba 06/03/2008

Calendulae herba (07/13) 28/01/2014

Calendulae flos 23/11/2005 Calendulae flos 1297 2

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 acris extractum spissum

normatum 2529

Capsici oleoresina raffinata et quantificata

2336

Capsici tinctura normata 2337

Carvi aetheroleum M (AESGP

09/10)

06/11/2008 Carvi aetheroleum 1817

Carvi fructus H (AESGP

09/10)

23/11/2005 Carvi fructus 1080 *

Caryophylli floris

aetheroleum

15/07/2010 Caryophylli floris aetheroleum 1091 2 *

Caryophylli flos L (AESGP

09/10)

12/03/2009 Caryophylli flos 376 2 *

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 5/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Centaurii herba 23/11/2005 Centaurii herba 1301

Centellae folium ***

Centellae asiaticae

herba

08/05/2008 Centellae asiaticae herba 1498 () 1 ***

Chamomillae romanae

flos

H (AESGP

09/10)

16/07/2009 Chamomillae romanae flos 380

Chelidonii herba 06/11/2008 Chelidonii herba 1861

Chelidonium majus

rhizoma

Cichorii intybi planta

tota1

Cichorium planta tota

()

Cichorii intybi folium2

Cichorii intybi radix 15/01/2009 x

Cimicifugae racemosae

rhizoma

07/09/2006 Cimicifugae rhizoma 2069 2

Cinnamomi camphorae

folium/cortex

(07/13) 28/01/2014 x

Cinnamomi corticis

aetheroleum

11/11/2009 Cinnamomi cassiae aetheroleum 1496

Cinnamomi zeylanicii corticis

aetheroleum 1501

Cinnamomi zeylanici folii

aetheroleum 1608

1 *

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 6/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Cinnamomi cortex 06/11/2008 Cinnamomi cortex 387

Cinnamomi corticis tinctura 1819

1 *

Cinnamomum

camphora, aetherolei

fractio solida

(07/13) d-Camphora 1400

Cistus creticus,

folium/resinum

(07/13) 28/01/2014

Citri bergami

aetheroleum

M (AESGP

09/10)

11/11/2009 Aurantii amari epicarpii et mesocarpii

tinctura 1604

Aurantii amari epicarpium et

mesocarpium 1603

Aurantii amari flos 1810

Aurantii dulcis aetheroleum 1811

Citrus limon succus ****

Colae semen M (AESGP

09/10)

16/07/2009 Colae semen 1504

Coptidis rhizoma Coptidis rhizoma 2715 (in prep.)

1

Crataegi folium cum

flore

AESGP

05/07

L (AESGP

09/10)

13/07/2007 Crataegi folium cum flore 1432

Crataegi folii cum flore extractum fluidum

quantificatum 1864

Crataegi folii cum flore extractum siccum

1865

2 ()

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 7/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Crataegi fructus3 AESGP

05/07

H (AESGP

09/10)

13/07/2007 Crataegi fructus 1220

Cucurbitae semen 10/01/2008 4

Curcurmae longae

rhizoma

23/11/2005 Curcurmae longae rhizoma 2543 (in

prep.)

1 *

Curcumae xanthorrhizae

rhizoma

H (AESGP

09/10)

06/11/2008 Curcumae xanthorrhizae rhizoma 1441

(in prep.)

Cyani flos (FR 07/13) 28/01/2014 x

Cydonia oblonga succus

Cynarae folium 13/07/2006 Cynarae folium 1866

Cynarae folii extractum siccum 2389

4

Dryopteris filix mas IVAA

05/07

Echinacea angustifolia

planta tota

Echinaceae angustifoliae

radix

13/07/2006 Echinaceae angustifoliae radix 1821 1

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 2282 (in prep.)

1

3 May 2014: Cancellation of assessment work Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 8/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Echinacea purpurea

planta tota

Echinaceae purpureae

radix

13/07/2006 Echinaceae purpureae radix 1824 1

Eleutherococci radix 23/11/2005 Eleutherococci radix 1419 2

Emblicae officinalis

fructus

AYUSH

08/2008

*

x

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

Eschscholziae herba

cum flore

22/11/2011

Eucalypti aetheroleum H (AESGP

09/10)

07/09/2007 Eucalypti aetheroleum 390 2

Eucalypti folium H (AESGP

09/10)

07/09/2007 Eucalypti folium 1320 2

Euphrasiae herba 06/11/2008

Filipendulae ulmariae

flos

06/03/2008

Filipendulae ulmariae

herba

06/03/2008 Filipendulae ulmariae herba 1868

Foeniculi amari fructus 23/11/2005 Foeniculi amari fructus 824 3 *

Foeniculi amari fructus

aetheroleum

23/11/2005 Foeniculi amari fructus aetheroleum 1826

Foeniculi amari herbae aetheroleum 2380

Foeniculi dulcis fructus 23/11/2005 Foeniculi dulcis fructus 825 *

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 9/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Fragaria vesca fructus

Fragariae folium H (AESGP

09/10)

10/01/2008

Frangulae cortex 23/11/2005 Frangulae cortex 25

Frangulae corticis extractum siccum

normatum 1214

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 x x x

Gentianae radix 07/09/2007 Gentianae radix 392

Gentianae tinctura 1870

3

Ginkgo bilobae folium L (AESGP

09/10)

07/09/2007 Ginkgonis extractum siccum normatum

2381 (in prep.)

Ginkgonis extractum siccum raffinatum et

quantificatum 1827

Ginkgonis folium 1828

1

Ginseng radix L (AESGP

09/10)

07/09/2007 Ginseng extractum siccum 2356

Ginseng radix 1523

1

Glycine max and/or

lecithin derived from

Glycine max (soy bean

lecithin)

(DE 07/13) 28/01/2014 x x

Grindeliae herba L (AESGP

09/10)

11/03/2010 x x x

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 10/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Hamamelidis cortex 23/11/2005 Hamamelidis cortex 2532 (in prep.) 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 (in prep.) x 2

Harpagophyti radix 23/11/2005 Harpagophyti radix 1095

Harpagophyti extractum siccum 1871

3

Hederae helicis folium 07/09/2007 Hederae folium 2148

Helichrysi flos (PL 07/13) 28/01/2014

Hippocastani cortex 06/05/2010

Hippocastani semen 07/09/2006 Hippocastani semen 1830 (in prep.)

Hippocastani seminis extractum siccum

normatum 1829 (in prep.)

2

Hyoscyami herba4 Hyoscyami folium 225 (deleted)

Hyoscyami tinctura 1873 (in prep.)

Hyoscyami pulvis normatus 226 (deleted)

Hyoscyami extractum siccum normatum

1872 (in prep.)

() *****

Hyperici herba 26/10/2006

Hyperici herba 1438

Hyperici herbae extractum siccum

quantificatum 1874

2

Hyperici oleum

Imperatoria ostruthium

rhizoma

4 November 2012: cancellation of assessment work Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 11/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Iridis rhizoma () *

Iris germanica rhizoma

Juglandis folium M (AESGP

09/10)

10/01/2008 **

Juniperi aetheroleum 17/09/2009 Juniperi aetheroleum 1832

Juniperi pseudo-fructus 06/03/2008 Juniperi galbulus 1532 ***

Juniperus communis

summitates

(FR 07/13) 28/01/2014 x x x ***

Lavandulae aetheroleum AESGP

10/08

15/01/2009 Lavandulae aetheroleum 1338 3

Lavandulae flos 15/01/2009 Lavandulae flos 1534

Leonuri cardiacae herba Company

08/09

17/09/2009 Leonuri cardiacae herba 1833

Leonuri herba 2785 (in prep.)

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)

*

Liquiritiae radix 03/07/2008 Liquiritiae extractum fluidum 2853 (in

prep.)

Liquiritiae extractum fluidum ethanolicum

normatum 1536

Liquiritiae extractum siccum ad

saporandum 2378

Liquiritiae radix 277

1 *

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 12/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Liquiritiae radix praeparata 2861 (in

prep.)

Lupuli flos 23/11/2005 Lupuli flos 1222 3

Lysimachia nummularia

herba

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

Matricariae extractum fluidum 1544

Matricariae flos

07/09/2007 Matricariae flos 404

Matricariae extractum fluidum 1544

1

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

Melissae folii extractum siccum 2524

Melissae folii extractum siccum

quantificatum 2311 (in prep.)

2

Menthae piperitae

aetheroleum

23/11/2005 Menthae piperitae aetheroleum 405

Menthae arvensis aetheroleum partim

mentholum depletum 1838

2

Menthae piperitae folium 23/11/2005 Menthae piperitae folium 406 Menthae

piperitae folii extractum siccum 2382

2

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 13/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Mercurialis perennis

planta tota

Millefolii flos 10/01/2008 Millefolii herba 1382

Millefolii herba 10/01/2008 Millefolii herba 1382 4

Myrrha (Commiphora

molmol)

06/10/2008 Myrrha 1349

Myrrhae tinctura 1877

3 *

Myrtilli folium M (AESGP

09/10)

16/07/2009

Myrtilli fructus siccus H (AESGP

09/10)

10/01/2008 Myrtilli fructus siccus 1588

Myrtilli fructus recens 1602

Myrtilli fructus recentis extractum siccum

raffinatum et normatum 2394

4

Ocimi sancti folium AYUSH

08/2008

2 **/***

*

Oenotherae biennis

oleum

06/11/2008 Oenotherae oleum raffinatum 2104

(deleted)

2

Oleae folium 31/10/2008 Oleae folium

Oleae folii extractum siccum 2313

Ononidis radix 24/01/2012 Ononidis radix 1879

Onopordon acanthium

flos

Origani dictamni herba 12/07/2011

(Origani herba 1880)

Origanum majoranae

fructus

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 14/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Origanum majoranae

herba

(AESGP

07/13)

28/01/2014 (Origani herba 1880) x x

Orthosiphonis folium 10/01/2008 Orthosiphonis folium 1229

Paeoniae radix (AESGP

07/13)

28/01/2014 Paeoniae radix alba 2424 (in prep.)

Paeoniae radix rubra 2425 (in prep.)

x 1 x

Paulliniae semen

(=Guaranae semen)

EDQM

(03/11)

31/03/2011 Guaranae semen 2669 (in prep.) x

Passiflorae herba 23/11/2005 Passiflorae herba 1459

Passiflorae herbae extractum siccum

1882

3

Pelargonii radix L (AESGP

09/10)

16/07/2009 Pelargonii radix 2264

Phaseoli fructus (sine

semine)

13/09/2011 ***

Picrorhizae kurroae

rhizoma

AYUSH

08/2008

12/07/2011 Picrorhizae kurroae rhizoma et radix 2744

(in prep.)

4 ** x

Pilosellae herba cum

flore

22/11/2011 Hieracium pilosella 2822 (in prep.)

Piperis methystici

rhizoma

2

Piperis nigri fructus Piperis fructus 2477

Piperis longi fructus 2453

**,***

Pistacia lentiscus,

resinum (Mastix)

(07/13) 28/01/2014 *****

Plantaginis lanceolatae

folium

07/09/2007 Plantaginis lanceolatae folium 1884 ()

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 15/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Plantaginis ovatae

semen

23/03/2005 Plantaginis ovatae semen 1333 1

Plantaginis ovatae

seminis tegumentum

23/03/2005 Plantaginis ovatae seminis tegumentum

1334

3

Platycodi radix Platycodonis radix 2660 (in prep.) 1

Polygalae radix5

(= Senegae radix)

Polygalae radix 202 2

Polygoni avicularis herba (PL 07/13) 28/01/2014 Polyrgoni avicularis herba 1885 x x x

Polypodii rhizoma 08/03/2007

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 flos6 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 ****

Rauwolfiae radix 1

*****

Resina laricis

(see Terebinthinae

laricina)

5 September 2007: cancellation of assessment work 6 March 2012: Cancellation of assessment work Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 16/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Rhamni purshianae

cortex

23/11/2005 Rhamni purshianae cortex 105

Rhamni purshianae extractum siccum

normatum 1844

2

Rhei radix 23/11/2005 Rhei radix 291

Rhei extractum siccum normatum 1845

(in prep.)

1

Rhodiolae roseae

rhizoma et radix

H (AESGP

09/10)

16/07/2009

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

x 4 */***

x

Rosae aetheroleum7

Rosae flos 12/07/2011

Rosmarini aetheroleum 15/01/2009 Rosmarini aetheroleum 1846

Rosmarini folium 07/09/2007 Rosmarini folium 1560

Rubi idaei folium 13/09/2011

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

Sabalis serrulatae extractum 2579

2

Saccharomyces

cerevisiae/

S. boulardii

(DE 07/13) 28/01/2014 x

Salix sp. cortex 23/11/2005 Salicis cortex 1583

Salicis corticis extractum siccum 2312)

4

7 March 2013: Cancellation of assessment work Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 17/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Salix sp. folium

Salviae officinalis

aetheroleum

17/09/2009 Salviae officinalis aetheroleum 2860 (in

prep.)

Salviae lavandulifoliae aetheroleum 1849

Salviae sclareae aetheroleum 1850

Salviae officinalis folium 08/03/2007 Salviae officinalis folium 1370

Salviae tincture 1889

Salviae trilobae folium (07/13) 28/01/2014 Salviae trilobae folium 1561

Sambuci flos IVAA

05/07

08/03/2007 Sambuci flos 1217 2

Sambuci fructus 13/09/2011

Scolopendrium officinale

folium

2

Sennae folium 31/05/2005 Sennae folium 206

Sennae folii extractum siccum normatum

1261

1 *

Sennae fructus 31/05/2005 Sennae fructus angustifoliae 208 Sennae

fructus acutifoliae 207 .)

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

Silybi mariani extractum siccum

raffinatum et normatum 2071

2

Sisymbrii officinalis

herba (Erysimi officinalis

herba)

H (AESGP

09/10)

27/01/2011 x

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 18/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Solani dulcamarae

stipites

L (AESGP

09/10)

06/03/2008

Solidaginis virgaureae

herba

23/11/2005 Solidaginis virgaureae herba 1893

Solidaginis herba 1892

Storax/ Benzoe tincture Benzoe sumatranus 1814

Benzoe tonkinensis 2158

Benzois sumantrani tinctura 1813

Benzois tonkinensis tinctura 2157

Symphyti radix 08/05/2008

Tanaceti parthenii herba 08/05/2008 Tanaceti parthenii herba 1516 2

Taraxaci folium 06/03/2008 ()

Taraxaci radix cum

herba

(= Taraxacum officinale

planta tota)

07/09/2007 Taraxaci officinalis herba cum radice

1851

Taraxaci officinalis radix 1852

() ()

3

Terebinthinae laricina8

(Resina laricis)

Terebinthinae aetheroleum e Pino

pinastro 1627

Thymi aetheroleum 07/09/2007 Thymi typo thymolo aetheroleum 1374

Thymi herba 23/11/2005 Thymi herba 865

Thymi extractum liquidum normatum

1894 (in prep.)

1

Thymi herba/Primulae

radix

fixed combination

07/09/2007 Thymi herba 865

Primulae radix 1364

8 May 2010: Cancellation of assessment work Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 19/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

Tiliae flos H (AESGP

09/10)

11/03/2010 Tiliae flos 957 x

Tiliae tomentosae flos L (AESGP

09/10)

11/03/2010 Tiliae flos 957

Tormentillae rhizoma 03/07/2008 Tormentillae rhizoma 1478

Tormentillae tinctura 1895

Trigonellae foenugraeci

semen

(Foenugraeci semen )

10/01/2008 Trigonellae foenugraeci semen 1323 3 **

Uncariae tomentosae

cortex

16/07/2010 Uncariae tomentosa cortex 2530 (in

prep.)

Urtica dioica flos

Urticae folium 23/11/2005 Urticae folium 1897

Urticae herba 23/11/2005

Urticae radix 23/11/2005 Urticae radix 2538 (in prep.) 2

Uvae ursi folium 23/11/2005 Uvae ursi folium 1054 2

Valerianae radix 27/01/2005 Valerianae extractum aquosum siccum

2400Valerianae extractum

hydroalcoholicum siccum 1898

Valerianae radix 453

Valerianae radix minutata 2526

(Valerianae tinctura 1899

1 *

Valerianae radix/

Lupuli flos

fixed combination

31/10/2007 Valerianae radix 453

Lupuli flos 1222

Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 20/21

A

B

Total

priority

2005

C

Later

request IP

or NCA

D

Added to

HMPC

Priority list

E

Ph. Eur.

related monographs

(July 2013)

F

ESCOP

Mon.

G

German

Comm. E

Mon.

H

French

Avis a.

fabr.

I

WHO

Mon.

K

Indian

Mon.

L

Chin.

Ph.

Mon.

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 (in prep.)

Vitis viniferae folium 31/10/2008 Vitis viniferae folium 2667 (in prep.) ***

Withaniae somniferae

radix

AYUSH

08/2008

12/07/2011 Withaniae somniferae radix 2746 (in

prep.)

4 */

Zingiberis rhizoma 23/11/2005 Zingiberis rhizoma 1522 1 *

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