inventory of herbal substances for assessment · acori graminei et acori tatarinowii rhizomae ad...

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23 November 2018 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 /33

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

10/01/2008 Agrimoniae herba × × × (×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(09/10) 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 ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

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

07/09/2007 Arnicae flos 1391 × × × 3




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(09/10)

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.)

× ×

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 × × ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

1174

Boldi folium ●● 23/11/2005 Boldi folium 1396 × × ×

Bruceae fructus ○ 1 ×

Bryophyllum folium =

Kalanchoe pinnata folium

●●

Bupleuri radix ○ Bupleuri radix

2562

1 ×

Bursae pastoris herba ○ 06/03/2008 Bursae pastoris

herba 2947

(in prep.)

× ×

Calendulae flos ●●●○ 23/11/2005 Calendulae flos

1297

× × × 2

NIS

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

1297

(×) × (×) ( 2 )

(NIS)

Camelliae sinensis non

fermentata folia

EDQM (03/11)

31/03/2011 Camelliae sinensis

non fermentata

folia 2668

×

Capsici fructus M AESGP (09/10)

31/03/2011 Capsici fructus

1859

Capsici oleoresina

raffinata et

normata 2336

× × × ×

Carvi aetheroleum ○ M AESGP

06/11/2008 Carvi (×) × (×) (1) (4)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(09/10)

aetheroleum 1817

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 ●● Chelidonii herba (×) (×) N I S (×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

rhizoma 1861

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 ×

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

× (×)

× 1 (1)

6

(1) ×

1 January 2010: Cancellation of assessment work 2 May 2012: Cancellation of assessment work 3 September 2015: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Cinnamomi

zeylanici folii

aetheroleum 1608

Cinnamomi cortex

387

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

× × ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

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 × ×

4 May 2014: Cancellation of assessment work 5 November 2014: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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

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

× × 1




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

purpureae herbae

succus expressus

et ethanolo

confirmatus 2282

(in prep.)

Echinacea purpurea planta

tota

● Echinaceae

purpureae herba

1823 Echinaceae

purpureae radix

1824

(×) (×) (1)

Echinaceae purpureae

radix

● 13/07/2006 Echinaceae

purpureae radix

1824

× × (1)

Ecliptae herba NL

(11/17)

Ecliptae herba

2564

(6) ×

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 13/07/2006 Equiseti herba × × NIS (×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(05/06) 1825

Eschscholziae herba cum

flore

22/11/2011 Eschscholzia

herba 3088 (in

prep.)

× ×

Eucalypti aetheroleum ● H

AESGP

(09/10)

07/09/2007 Eucalypti

aetheroleum 390

× × (×) 2 6 (7) ×

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

(×) × (×) ( 3 )

(NIS)

(1) (×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Foeniculi amari

herbae

aetheroleum 2380

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

× × ×

Gentianae radix ●●● 07/09/2007 Gentianae radix

392

× × × 3 (×)

Ginkgo bilobae folium ●●● L 07/09/2007 Ginkgonis folium × × 1 ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

AESGP

(09/10)

1828

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

× × ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Helichrysi flos PL

(07/13)

28/01/2014 Helichrysi flos

3089 (in prep.)

× NIS

Herniariae herba AT/ES

(11/17)

30/01/2018 ×

Hippocastani cortex ● 06/05/2010 Hippocastani

cortex 2945 (in

prep.)

(×) × × (2) (×)

Hippocastani semen ●●●● 07/09/2006 Hippocastani

semen 1830

× × × 2 (×)

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 ● × (×)

6 November 2012: cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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

Leonuri cardiacae herba Company

(08/09)

17/09/2009 Leonuri cardiacae

herba 1833

Leonuri herba

2785 (in prep.)

× NIS (×)

7 July 2015: cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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 07/09/2007 Marrubii herba × × ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

AESGP

(09/10)

1835

Mate folium ● 07/09/2007 Mate folium 2678 × ×

Matricariae aetheroleum 07/09/2007 Matricarieae

aetheroleum 1836

(×) (×) (×) (1)

Matricariae flos ●●●● 07/09/2007 Matricariae flos

404

× × × 1

NIS

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

× × × 2

NIS

(×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Menthae arvensis

aetheroleum

partim

mentholum

depletum 1838

Menyanthidis trifoliatae

folium

PL

(10/17)

30/01/2018 Menyanthidis

trifoliatae folium

1605

× ×

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


siccus 1588

× × × 4

8 November 2014: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(09/10)

Myrtilli fructus recens ● H

AESGP

(09/10)


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

× 1 ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Paeoniae radix

rubra 2425

Passiflorae herba ●●● 23/11/2005 Passiflorae herba

1459

× × × 3

Paulliniae semen

(=Guaranae semen)

EDQM

(03/11)

31/03/2011 Guaranae semen

2669

×

Pelargonii radix L

AESGP

(09/10)

16/07/2009 Pelargonii radix

2264

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 ● 07/09/2007 Plantaginis × (×) × 6 (×)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

folium lanceolatae folium

1884

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

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

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

9 September 2007: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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 × × ×

Pueraria lobatae radix NL

(11/17)

Puerariae lobatae

radix 2434

(6) ×

Quercus cortex ○ 10/01/2008 Quercus cortex

1887

× (4)

Rauwolfiae radix ○○ × 1 5 8

Rehmannia radix

(in combination:

Rehmannia 6 - ‘Liu wei di

huang wan’)

NL

(11/17)

Rehmanniae radix

2569 (in prep.)

×

Resina laricis

(see Terebinthinae laricina)

○

Rhamni purshianae cortex ●●○ 23/11/2005 Rhamni

purshianae cortex

105

× × × 2

10 March 2012: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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)

×

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

11 March 2013: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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 miltiorrhizae radix

et rhizoma

NL

(11/17)

30/01/2018 Salviae

miltiorrhizae radix

et rhizoma 2663

×

Salviae officinalis

aetheroleum

17/09/2009 Salviae officinalis

aetheroleum 2860

(in prep.)

Salviae

lavandulifoliae

aetheroleum 1849

Salviae sclareae

aetheroleum 1850

(×) (×) (×) ( N I S )




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

Salviae officinalis folium ●●●● 08/03/2007 Salviae officinalis

folium 1370

× × × NIS

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 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

Siegesbeckia orientalis

herba

NL

(11/17)

×

Silybi mariani fructus

(Cardui mariae fructus)

●●● M

AESGP

(09/10)

11/03/2010 Silybi mariani

fructus 1860

× × 2 2 ×

Sisymbrii officinalis herba H 27/01/2011 Sisymbrii ×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

(Erysimi officinalis herba) AESGP

(09/10)

officinalis herba

2942

(in prep.)

Solani dulcamarae stipites ○ L

AESGP

(09/10)

06/03/2008 ×

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 pectorales SK

(10/17)

Species sedativae AT/DE

(11/16)

29/01/2017

Storax/ Benzoe tincture ● Benzoe

sumatranus 1814

Benzoe

×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

tonkinensis 2158

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

12 May 2010: Cancellation of assessment work




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

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

Tiliae tomentosae flos L

AESGP

(09/10)

11/03/2010 Tiliae flos 957 × (×) ( N I S )

Tormentillae rhizoma ● 03/07/2008 Tormentillae

rhizoma 1478

× × ×

Tribulus terrestris herba CZ

(11/17)

4 6 ×

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

(×) (×) (×) ( 2 )

(NIS)




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

2538

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/

Lupuli flos

31/10/2007 Valerianae radix

453

×




Proposal after


Added to HMPC

Priority list

Ph. Eur. related


2015)

ESCOP German Comm.

E


WHO Indian Ph. Ch.

a b c

fixed combination Lupuli flos 1222

Verbasci flos ● 08/03/2007 Verbasci flos

1853

× × ×

Verbenae citriodorae folium ES

(11/17)

30/01/2018 Verbenae

citriodorae folium

1834

× ×

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 · acori graminei et acori tatarinowii rhizomae ad...

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