Inventory of herbal substances for assessment

Transcription

1 31 January 2017 MA//494079/2007 proposed to for assessment 30 Churchill Place Canary Wharf London 14 5U United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the uropean Union uropean Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 proposed to for assessment Column A: (working term) proposed for uropean Union herbal monograph/uropean Union entry establishment Column B: after survey among interested parties (IPs) (AFMUTA, ASGP, FCAM,, GA, IVAA, PS) mentions with high, medium or not specified, mentions with low Column C: Assessment proposal by IPs or National Competent Authorities (NCAs) after Abbreviation IP or Member State NCA (mm/yy), H=High, M=Medium, L=Low Column D: the for assessment (MA//278067/2006), Specified date (dd/mm/yyyy) Related Ph. ur. monographs on quality Column : Related herbal substance monographs on quality in the uropean Pharmacopoeia Specified monograph term and Ph. ur. 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: monographs published monographs (2 nd ed. including suppl. 2009; individual monographs published online by Jun 2015) Column G: Commission monographs (BfArM) monographs published successively until 1994 (corrections until 2002) Column H: Avis aux fabricants (AFSSAPS) 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), Medicinal plants commonly used in the Newly Independent States (2010) Column J: Indian monographs a: monograph in the Ayurvedic Pharmacopoeia of India, 1 st 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) MA//494079/2007 Page 2/22

3 after by Ph. ur. Absinthii herba 23/11/ 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 Agrimoniae herba M Agropyri repentis rhizoma M Allii cepae bulbus M Allii sativi bulbus H Aloe 23/11/ Aloe barbadensis /01/2008 Agrimoniae herba 1587 () 10/01/2008 Graminis rhizoma /03/ /11/ Allii sativi bulbi pulvis Aloe capensis Aloe vera gel Aloe barbadensis 257 Aloe capensis 258 Althaeae radix 07/09/2006 Althaeae radix 1126 Althaeae folium 1856 () () 1 (1) (1) () 2 5 Andrographidis herba Andrographis herba MA//494079/2007 Page 3/22

4 after by Ph. ur. Andrographidis paniculatae folium M 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 Anisi aetheroleum 23/11/ Anisi aetheroleum 804 () () () 3 (5) (5) Anisi fructus 23/11/ Anisi fructus (5) Arctii folium (Bardanae folium) Arctii radix (Lappa major radix; Bardanae radix) Arctii radix 2943 (in prep.) () 06/11/2008 Arctii radix 2943 (in prep.) () Arnicae flos M 07/09/2007 Arnicae flos Arnica montana planta tota Aspidium filix-mas folium Arnicae flos 1391 () () () (3) Astragali radix Astragali mongholici radix Avenae fructus 13/07/2006 Avenae sativae seminis pulvis 2539 (in prep.) Avenae herba 2618 (in prep.) MA//494079/2007 Page 4/22

5 after by Ph. ur. 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 ASGP (07/13) 28/01/2014 Balsamum peruvianum 754 Balsamum tolutanum 1596 Betulae folium 23/11/ Betulae folium 1174 Boldi folium 23/11/ Boldi folium 1396 Bruceae fructus 1 Bryophyllum folium = Kalanchoe pinnata folium Bupleuri radix Bupleuri radix 2562 (in prep.) 1 Bursae pastoris herba 06/03/2008 Bursae pastoris herba 2947 (in prep.) Calendulae herba (07/13) 28/01/2014 Calendulae flos 1297 () () (2) Calendulae flos 23/11/ Calendulae flos () Camelliae sinensis non fermentata folia Capsici fructus DQM (03/11) 31/03/2011 Camelliae sinensis non fermentata folia 2668 (in prep.) M 31/03/2011 Capsici fructus 1859 Capsici oleoresina raffinata et normata 2336 MA//494079/2007 Page 5/22

6 after by Carvi aetheroleum M Ph. ur. 06/11/2008 Carvi aetheroleum 1817 () () (1) (4) Carvi fructus H 23/11/ Carvi fructus Caryophylli floris aetheroleum 15/07/2010 Caryophylli floris aetheroleum 1091 (2) 6 8 () Caryophylli flos L 12/03/2009 Caryophylli flos 376 () Centaurii herba 23/11/ 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 16/07/2009 Chamomillae romanae flos 380 Chelidonii herba 06/11/2008 Chelidonii herba 1861 Chelidonium majus rhizoma Chelidonii herba 1861 () () () () Cichorii intybi planta tota 1 Cichorium planta tota Cichorii intybi radix 2948 (in prep.) () (3) Cichorii intybi folium 2 Cichorii intybi radix 2948 (in prep.) () () (3) () Cichorii intybi radix 15/01/2009 Cichorii intybi radix 2948 (in prep.) 3 1 January 2010: Cancellation of assessment work 2 May 2012: Cancellation of assessment work MA//494079/2007 Page 6/22

7 Cimicifugae racemosae rhizoma after by Ph. ur. 07/09/2006 Cimicifugae rhizoma () Cinnamomi camphorae (07/13) 28/01/2014 Cinnamomi cortex 387 d-camphora folium/cortex () (6) 3 () Cinnamomi corticis 11/11/2009 Cinnamomi cassiae aetheroleum 1496 () 1 (1) (1) aetheroleum Cinnamomi zeylanici corticis 6 aetheroleum 1501 Cinnamomi zeylanici folii aetheroleum 1608 Cinnamomi cortex 387 Cinnamomi cortex 06/11/2008 Cinnamomi cortex Cinnamomum camphora, aetherolei fractio solida Cistus creticus, folium/resinum (07/13) d-camphora 1400 () 6 3 () (07/13) 28/01/2014 Citri bergami M 11/11/2009 Aurantii amari epicarpium et aetheroleum mesocarpium 1603 Aurantii amari flos 1810 Aurantii dulcis aetheroleum 1811 Citrus limon succus 4 Colae semen M 16/07/2009 Colae semen September 2015: Cancellation of assessment work MA//494079/2007 Page 7/22

8 after by Ph. ur. Coptidis rhizoma Coptidis rhizoma Crataegi folium cum ASGP (05/07) 13/07/2007 Crataegi folium cum flore () flore L (ASGP 09/10) Crataegi fructus 4 ASGP 05/07 H (ASGP 09/10) 13/07/2007 Crataegi fructus 1220 () (2) () () Cucurbitae semen 10/01/2008 Cucurbitae semen 2941 (in prep.) 4 Curcurmae longae rhizoma 23/11/ Curcurmae longae rhizoma Curcumae H 06/11/2008 Curcumae zanthorrhizae rhizoma zanthorrhizae 1441 rhizoma Cyani flos 5 FR (07/13) 28/01/2014 Cydonia oblonga succus Cynarae folium 13/07/2006 Cynarae folium Dryopteris filix-mas IVAA (05/07) 6 chinacea angustifolia planta tota chinaceae angustifoliae radix chinaceae angustifoliae radix /07/2006 chinaceae angustifoliae radix May 2014: Cancellation of assessment work 5 November 2014: Cancellation of assessment work MA//494079/2007 Page 8/22

9 chinaceae pallidae radix after by Ph. ur. 13/07/2006 chinaceae pallidae radix chinaceae purpureae herba chinacea purpurea planta tota 23/11/ chinaceae purpureae herba 1823 chinaceae purpureae herbae succus expressus et confirmatus sine ethanolo 2894 (in prep.) chinaceae purpureae herbae succus expressus et ethanolo confirmatus 2282 (in prep.) chinaceae purpureae herba 1823 chinaceae purpureae radix () () (1) chinaceae purpureae radix 13/07/2006 chinaceae purpureae radix 1824 (1) leutherococci radix 23/11/ leutherococci radix mblicae officinalis fructus AYUSH (08/08) 1 8 phedrae herba phedrae herba pilobii herba CZ (07/13) 28/01/2014 quiseti herba ASGP (05/06) 13/07/2006 quiseti herba 1825 () schscholziae herba cum flore ucalypti aetheroleum H 22/11/ /09/2007 ucalypti aetheroleum 390 () 2 6 (7) MA//494079/2007 Page 9/22

10 after by ucalypti folium H Ph. ur. 07/09/2007 ucalypti folium 1320 () 2 5 (7) () uphrasiae herba 06/11/2008 Filipendulae ulmariae flos Filipendulae ulmariae herba 06/03/2008 Filipendulae ulmariae herba 1868 () 06/03/2008 Filipendulae ulmariae herba 1868 Foeniculi amari fructus 23/11/ Foeniculi amari fructus Foeniculi amari fructus 23/11/ Foeniculi amari fructus aetheroleum () () (3) (1) () aetheroleum 1826 () Foeniculi amari herbae aetheroleum 2380 Foeniculi dulcis fructus 23/11/ Foeniculi dulcis fructus Fragaria vesca fructus () () Fragariae folium H 10/01/2008 Frangulae cortex 23/11/ Frangulae cortex 25 2 Fraxini folium L 16/07/2009 Fraxini folium 1600 Fraxini rhynchophyllae cortex 2452 () Fucus vesiculosus 13/09/2011 Fucus vel Ascophyllum 1426 Fumariae herba M 11/03/2010 Fumariae herba 1869 MA//494079/2007 Page 10/22

11 after by Ph. ur. Gentianae radix 07/09/2007 Gentianae radix () Ginkgo bilobae folium L 07/09/2007 Ginkgonis folium Ginseng radix L 07/09/2007 Ginseng radix Glycine max and/or lecithin derived from Glycine max (soy bean lecithin) D (07/13) 28/01/2014 Grindeliae herba L 11/03/2010 Grindeliae herba 2951 (in prep.) Hamamelidis cortex 23/11/ Hamamelidis cortex 2532 () 2 Hamamelidis folium 23/11/ Hamamelidis folium Hamamelidis folium et cortex aut ramunculus destillatum Hamamelidis aqua 23/11/ Hamamelidis aqua 2533 (deleted) () 2 Harpagophyti radix 23/11/ Harpagophyti radix Hederae helicis folium 07/09/2007 Hederae folium 2148 Helichrysi flos PL (07/13) 28/01/2014 Hippocastani cortex 06/05/2010 Hippocastani cortex 2945 (in prep.) () (2) () Hippocastani semen 07/09/2006 Hippocastani semen () MA//494079/2007 Page 11/22

12 after by Ph. ur. Hyoscyami herba 6 Hyoscyami folium 225 (deleted) Hyoscyami pulvis normatus 226 (deleted) () (5) (4) () Hyperici herba 26/10/2006 Hyperici herba Hyperici oleum Hyperici herba 1438 () () () (2) () 2 (2) () Imperatoria ostruthium rhizoma Iridis rhizoma () Iris germanica rhizoma Juglandis folium M 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 Juniperus communis FR (07/13) 28/01/2014 Juniperi galbulus 1532 summitates 7 Juniperi aetheroleum () () (3) Lavandulae aetheroleum ASGP (10/08) 15/01/2009 Lavandulae aetheroleum 1338 () () 3 Lavandulae flos 15/01/2009 Lavandulae flos November 2012: cancellation of assessment work 7 July 2015: cancellation of assessment work MA//494079/2007 Page 12/22

13 Leonuri cardiacae herba after by Company (08/09) Ph. ur. 17/09/2009 Leonuri cardiacae herba 1833 Leonuri herba 2785 (in prep.) () Levistici radix H 10/01/2008 Levistici radix 1233 Lichen islandicus L 23/11/ Lichen islandicus Lini semen 27/01/ Lini semen 95 Lini oleum virginale 1908 (deleted) 1 Liquiritiae radix 03/07/2008 Liquiritiae radix 277 Liquiritiae radix praeparata 2861 (deleted) 1 1 Lupuli flos 23/11/ Lupuli flos 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 1835 Mate folium 07/09/2007 Mate folium 2678 (in prep.) Matricariae aetheroleum 07/09/2007 Matricarieae aetheroleum 1836 () () () (1) Matricariae flos 07/09/2007 Matricariae flos MA//494079/2007 Page 13/22

14 Melaleucae alternifoliae aetheroleum after by H Ph. ur. 06/11/2008 Melaleucae aetheroleum Meliloti herba 23/11/ Meliloti herba 2120 Melissae folium 23/11/ Melissae folium Menthae piperitae 23/11/ Menthae piperitae aetheroleum 405 () 2 () aetheroleum Menthae arvensis aetheroleum partim mentholum depletum 1838 Menthae piperitae 23/11/ Menthae piperitae folium () folium Menthae arvensis aetheroleum partim mentholum depletum 1838 Mercurialis perennis planta tota Millefolii flos 10/01/2008 Millefolii herba 1382 () () (4) () Millefolii herba 10/01/2008 Millefolii herba (5) () (5) () Myrrha (Commiphora molmol) 06/10/2008 Myrrha (1) (3) Myrtilli folium 8 M 16/07/2009 Myrtilli fructus siccus 1588 () (4) Myrtilli fructus recens 1602 Myrtilli fructus siccus H 10/01/2008 Myrtilli fructus siccus November 2014: Cancellation of assessment work MA//494079/2007 Page 14/22

15 after by Myrtilli fructus recens H Ph. ur. 01/07/2014 Myrtilli fructus recens 1602 () 4 Ocimi sancti folium AYUSH (08/08) 2 2 (4) 2 (5) Oenotherae biennis oleum 06/11/2008 Oenotherae oleum raffinatum 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 Origanum majoranae herba (Origani herba 1880) () ASGP (07/13) 28/01/2014 (Origani herba 1880) Orthosiphonis folium 10/01/2008 Orthosiphonis folium 1229 Paeoniae radix ASGP (07/13) 28/01/2014 Paeoniae radix alba 2424 Paeoniae radix rubra Passiflorae herba 23/11/ Passiflorae herba Paulliniae semen (=Guaranae semen) DQM (03/11) 31/03/2011 Guaranae semen 2669 (in prep.) Pelargonii radix L 16/07/2009 Pelargonii radix 2264 MA//494079/2007 Page 15/22

16 Phaseoli fructus (sine semine) after by Ph. ur. 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 D (05/15) 05/05/ Piperis nigri fructus Piperis fructus 2477 Piperis longi fructus Pistacia lentiscus, resinum (Mastix) Plantaginis lanceolatae folium (07/13) 28/01/2014 Mastix /09/2007 Plantaginis lanceolatae folium 1884 () 6 () Plantaginis ovatae semen 23/03/ Plantaginis ovatae semen (3) () Plantaginis ovatae 23/03/ Plantaginis ovatae seminis 3 () seminis tegumentum tegumentum 1334 (1) Platycodi radix Platycodonis radix 2660 (in prep.) 1 Polygalae radix 9 (= Senegae radix) Polygoni avicularis herba Polygalae radix PL (07/13) 28/01/2014 Polygoni avicularis herba 1885 Polypodii rhizoma 08/03/2007 Polypodii rhizoma 2953 (in prep.) 9 September 2007: cancellation of assessment work MA//494079/2007 Page 16/22

17 after by Ph. ur. Primulae flos 13/07/2006 Primulae flos 2540 (in prep.) () Primulae radix 23/11/ Primulae radix 1364 Pruni africani cortex 12/07/2011 Pruni africanae cortex Pruni spinosae flos 10 M Pruni spinosae fructus Pruni spinosae M summitates 7 () Psyllii semen 23/03/ Psyllii semen 858 Quercus cortex 10/01/2008 Quercus cortex 1887 (4) Rauwolfiae radix Resina laricis (see Terebinthinae laricina) Rhamni purshianae cortex 23/11/ Rhamni purshianae cortex Rhei radix 23/11/ Rhei radix Rhodiolae roseae H 16/07/2009 Rhodiolae roseae rhizoma et radix () rhizoma et radix 2893 (in prep.) Ribis nigri folium 23/11/ Ribis nigri folium 2528 Ricini oleum PL (07/13) 28/01/2014 Ricini oleum virginale 0051 Ricini oleum raffinatum 2367 Ricini oleum hydrogenatum (1) (3) 10 March 2012: Cancellation of assessment work MA//494079/2007 Page 17/22

18 after by Ph. ur. Rosae aetheroleum 11 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 Rubi idaei folium 13/09/2011 Rubi idaei folium 2950 (in prep.) () Rusci aculeati rhizoma 13/07/2006 Rusci rhizoma 1847 Sabalis serrulatae L 07/09/2007 Sabalis serrulatae fructus fructus (Serenoae repentis fructus) Saccharomyces cerevisiae/ S. boulardii D (07/13) 28/01/2014 Salix sp. cortex 23/11/ Salicis cortex (6) Salix sp. folium Salicis cortex 1583 () () () (4) 6 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 trilobae folium (07/13) 28/01/2014 Salviae trilobae folium March 2013: Cancellation of assessment work MA//494079/2007 Page 18/22

19 after by Ph. ur. Sambuci flos IVAA (05/07) 08/03/2007 Sambuci flos Sambuci fructus 13/09/2011 Sambuci flos 1217 () () () (2) Scolopendrium officinale folium Sennae folium 31/05/ Sennae folium Sennae fructus 31/05/ Sennae fructus angustifoliae (1) 1 () Sennae fructus acutifoliae 207 () Sideritis herba (07/13) 28/01/2014 Silybi mariani fructus M 11/03/2010 Silybi mariani fructus (Cardui mariae fructus) Sisymbrii officinalis H 27/01/2011 Sisymbrii officinalis herba 2942 herba (rysimi (in prep.) officinalis herba) Solani dulcamarae L 06/03/2008 Solani dulcamarae stipites 2944 stipites (in prep.) Solidaginis virgaureae herba 23/11/ Solidaginis virgaureae herba 1893 Solidaginis herba 1892 () Species amarae AT/D (11/16) 29/01/2017 Species digestivae or Species stomachicae AT/D (11/16) 29/01/2017 Species diureticae AT (11/15) 24/11/2015 Species sedativae AT/D (11/16) 29/01/2017 Storax/ Benzoe tincture Benzoe sumatranus 1814 Benzoe tonkinensis 2158 MA//494079/2007 Page 19/22

20 after by Ph. ur. Symphyti radix 08/05/2008 Tanaceti parthenii herba 08/05/2008 Tanaceti parthenii herba Taraxaci folium 06/03/2008 Taraxaci officinalis herba cum radice 1851 Taraxaci officinalis radix 1852 () (3) () () Taraxaci radix cum 07/09/2007 Taraxaci officinalis herba cum radice () () 3 () herba 1851 (= Taraxacum Taraxaci officinalis radix 1852 officinale planta tota) Terebinthinae laricina 12 (Resina laricis) Terebinthinae aetheroleum 1627 Thymi aetheroleum 07/09/2007 Thymi typo thymolo aetheroleum 1374 () () () (1) () Thymi herba 23/11/ Thymi herba Thymi herba/primulae radix fixed combination 07/09/2007 Thymi herba 865 Primulae radix 1364 Tiliae flos H 11/03/2010 Tiliae flos May 2010: Cancellation of assessment work MA//494079/2007 Page 20/22

21 Tiliae tomentosae flos after by L Ph. ur. 11/03/2010 Tiliae flos 957 () () Tormentillae rhizoma 03/07/2008 Tormentillae rhizoma 1478 Trigonellae foenugraeci semen (Foenugraeci semen ) 10/01/2008 Trigonellae foenugraeci semen Uncariae tomentosae cortex 16/07/2010 Uncariae tomentosa cortex 2530 (in prep.) 3 Urticae dioica flos Urticae folium 1897 Urticae radix 2538 () () () (2) () Urticae folium 23/11/ Urticae folium 1897 (2) () Urticae herba 23/11/ Urticae folium 1897 Urticae radix 2538 (2) () Urticae radix 23/11/ Urticae radix Uvae ursi folium 23/11/ Uvae ursi folium Vaccinii macrocarpi fructus Company (12/14) 29/09/2015 () () 4 Valerianae aetheroleum 27/01/ Valerianae radix 453 Valerianae radix minutata 2526 Valerianae radix 27/01/ Valerianae radix 453 Valerianae radix minutata 2526 () () (1) (1) 1 (1) Valerianae radix/ 31/10/2007 Valerianae radix 453 MA//494079/2007 Page 21/22

22 Lupuli flos fixed combination after by Ph. ur. Lupuli flos 1222 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 (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/ Zingiberis rhizoma (2) 8 MA//494079/2007 Page 22/22