Monographs - HMPC Escop Who Comm e 2011 Jul 26
Monographs - HMPC Escop Who Comm e 2011 Jul 26
Monographs - HMPC Escop Who Comm e 2011 Jul 26
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.
(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
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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
I WHO
K Indian
L Chinese
**
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
R PF P C F
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
*** *
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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
I WHO
K Indian
L Chinese
Althaeae radix
M (AESGP 09/10) R
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
3 3
E Ph. Eur. related monographs and status (June2011) Arnicae tinctura 1809/0 (6.3)
F ESCOP
G German Comm. E
I WHO
K Indian
L Chinese
F F
Avenae sativae seminis pulvis 2539/1 Avenae herba 2618/1 Balsamum peruvianum 754/5 (6.2) Balsamum tolutanum 1596/5 (6.0)
**
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
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F ESCOP
G German Comm. E
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
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
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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
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
Public statement
2
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
I WHO
K Indian
L Chinese
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
****
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E Ph. Eur. related monographs and status (June2011) Crataegi fructus 1220/2 (23.1) (6.0)
F ESCOP
G German Comm. E
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
Page 9/21
F ESCOP
G German Comm. E
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
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 *
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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
I WHO
K Indian
L Chinese
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)
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)
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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
I WHO
K Indian
L Chinese
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
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
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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
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
Page 13/21
F ESCOP
G German Comm. E
I WHO
K Indian
L Chinese
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
***
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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
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)
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)
Page 15/21
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
I WHO
K Indian
L Chinese
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 *
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E Ph. Eur. related monographs and status (June2011) et normatum 2394/5 (18.4) (6.4)
F ESCOP
G German Comm. E
I WHO
K Indian
L Chinese
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
(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)
Page 17/21
E Ph. Eur. related monographs and status (June2011) Pelargonii radix 2264/5 (17.3) (6.0)
F ESCOP
G German Comm. E
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
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
F ESCOP
G German Comm. E
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)
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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
I WHO
K Indian
L Chinese
L (AESGP 09/10)
Salicis cortex 1583/2 (22.4) (6.8) Salicis corticis extractum siccum 2312/5 (18.1) (6.1)
F Salviae officinalis folium 1370/1 (6.0) Salviae tincture 1889/5 (6.0) Salviae lavandulifoliae aetheroleum 1849/5 (18.4) (7.0)
Page 20/21
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
I WHO
K Indian
L Chinese
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)
M (AESGP 09/10)
Silybi mariani fructus 1860/5 (6.0) Silybi mariani extractum siccum raffinatum et normatum 2071/5 (17.1) (6.0)
F ESCOP
G German Comm. E
I WHO
K Indian
L Chinese
Solidaginis virgaureae herba 1893/2 (22.4) (6.0) Solidaginis herba 1892/5 (6.0)
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
E Ph. Eur. related monographs and status (June2011) Thymi typo thymolo aetheroleum 1374/5 (22.2) (7.3)
F ESCOP
G German Comm. E
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 865/1 (19.2) (6.4) Primulae radix 1364/2 (23.3) (6.0)
Tiliae flos
H (AESGP 09/10)
L (AESGP 09/10)
Tormentillae rhizoma
F R
**
E Ph. Eur. related monographs and status (June2011) Urticae folium 1897/5 (21.1) (7.0)
F ESCOP
G German Comm. E
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
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
I WHO
K Indian
L Chinese
Visci albi herba Vitis viniferae folium Withaniae somniferae radix Zingiberis rhizoma
4 1 * ***
Page 25/21