Inventory of herbal substances for assessment

Transcription

1 23 November 2018 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: survey among interested parties (IPs) (AFMUTA,, FCAM, SCOP, GA, IVAA, PS) mentions with high, medium or not specified, mentions with low Column C: Assessment proposal by IPs or National Competent Authorities (NCAs) 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. on quality Column : Related herbal substance 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 ( of herbal substances with deviating species or plant part are in brackets) Column F: SCOP published (2 nd ed. including suppl. 2009; individual published online by Jun Column G: Commission (BfArM) 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 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 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 monograph in Chinese Pharmacopoeia (PPRC, Vol. 1 Traditional Chinese Materia Medica, 2010) MA//494079/2007 Page 2/33

3 A B C D F G H I J K Ph. ur. SCOP Absinthii herba 23/11/ Absinthii herba 1380 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.) (6) 2 1 Adhatodae vasicae folium AYUSH 12/07/2011 Adhatodae 1 1 (08/08) vasicae folium 2738 (in prep.) Agni casti fructus 07/09/2007 Agni casti fructus Agrimoniae herba M 10/01/2008 Agrimoniae herba () MA//494079/2007 Page 3/33

4 A B C D F G H I J K Ph. ur. SCOP 1587 Agropyri repentis rhizoma M 10/01/2008 Graminis rhizoma 1306 Allii cepae bulbus M 11/03/ Allii sativi bulbus H 23/11/ Allii sativi bulbi pulvis Aloe 23/11/ Aloe barbadensis 257 Aloe capensis Aloe vera gel Aloe barbadensis 257 Aloe capensis 258 Althaeae radix 07/09/2006 Althaeae radix 1126 Althaeae folium 1856 Andrographidis herba Andrographis herba 2712 () () 1 (1) (1) () MA//494079/2007 Page 4/33

5 A B C D F G H I J K Ph. ur. SCOP 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 2557 Anisi aetheroleum 23/11/ Anisi aetheroleum () () () 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 MA//494079/2007 Page 5/33

6 A B C D F G H I J K Ph. ur. SCOP Arnica montana planta tota Arnicae flos 1391 () () () (3) Aspidium filix-mas folium Astragali radix Astragali mongholici radix 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 Bacopa monnieri (2) (1) (8) (08/08) 2850 (in prep.) Balsamum peruvianum (07/13) 28/01/2014 Balsamum peruvianum 754 Balsamum tolutanum 1596 Betulae folium 23/11/ Betulae folium MA//494079/2007 Page 6/33

7 A B C D F G H I J K Ph. ur. SCOP 1174 Boldi folium 23/11/ Boldi folium 1396 Bruceae fructus 1 Bryophyllum folium = Kalanchoe pinnata folium Bupleuri radix Bupleuri radix Bursae pastoris herba 06/03/2008 Bursae pastoris herba 2947 (in prep.) Calendulae flos 23/11/ Calendulae flos Calendulae herba (07/13) 28/01/2014 Calendulae flos () () ( 2 ) 1297 () Camelliae sinensis non DQM 31/03/2011 Camelliae sinensis fermentata folia (03/11) non fermentata folia 2668 Capsici fructus M 31/03/2011 Capsici fructus 1859 Capsici oleoresina raffinata et normata 2336 Carvi aetheroleum M 06/11/2008 Carvi () () (1) (4) MA//494079/2007 Page 7/33

8 A B C D F G H I J K Ph. ur. SCOP aetheroleum 1817 Carvi fructus H 23/11/ Carvi fructus 1080 Caryophylli floris 15/07/2010 Caryophylli floris aetheroleum aetheroleum (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 Centellae asiaticae herba 08/05/2008 Centellae asiaticae herba 1498 () () () (1) (4) (1) (8) () () 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 Chelidonii herba () () N I S () MA//494079/2007 Page 8/33

9 A B C D F G H I J K Ph. ur. SCOP rhizoma 1861 Cichorii intybi planta tota 1 Cichorii intybi () (3) Cichorium planta tota radix 2948 (in prep.) Cichorii intybi folium 2 Cichorii intybi () () (3) () radix 2948 (in prep.) Cichorii intybi radix 15/01/2009 Cichorii intybi radix 2948 (in prep.) 3 Cimicifugae racemosae rhizoma 07/09/2006 Cimicifugae rhizoma () Cinnamomi camphorae (07/13) 28/01/2014 Cinnamomi cortex folium/cortex d-camphora 1400 () (6) 3 () Cinnamomi corticis 11/11/2009 Cinnamomi () 1 (1) (1) aetheroleum cassiae 6 aetheroleum 1496 Cinnamomi zeylanici corticis aetheroleum January 2010: Cancellation of assessment work 2 May 2012: Cancellation of assessment work 3 September 2015: Cancellation of assessment work MA//494079/2007 Page 9/33

10 A B C D F G H I J K Ph. ur. SCOP 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 aetheroleum M 11/11/2009 Aurantii amari epicarpium et mesocarpium 1603 Aurantii amari flos 1810 Aurantii dulcis aetheroleum 1811 Citrus limon succus 4 Colae semen M 16/07/2009 Colae semen 1504 MA//494079/2007 Page 10/33

11 A B C D F G H I J K Ph. ur. SCOP Coptidis rhizoma Coptidis rhizoma Crataegi folium cum flore 13/07/2007 Crataegi folium 2 () (05/07) cum flore 1432 L ( 09/10) Crataegi fructus 4 13/07/2007 Crataegi fructus () ( 2 ) () 05/ () H ( 09/10) Cucurbitae semen 10/01/2008 Cucurbitae semen 2941 (in prep.) Curcurmae longae rhizoma 23/11/ Curcurmae longae rhizoma Curcumae zanthorrhizae H 06/11/2008 Curcumae rhizoma zanthorrhizae rhizoma 1441 Cyani flos 5 FR (07/13) 28/01/ May 2014: Cancellation of assessment work 5 November 2014: Cancellation of assessment work MA//494079/2007 Page 11/33

12 A B C D F G H I J K Ph. ur. SCOP Cydonia oblonga succus Cynarae folium 13/07/2006 Cynarae folium Dryopteris filix-mas IVAA (05/07) 6 chinacea angustifolia chinaceae planta tota angustifoliae radix 1821 chinaceae angustifoliae radix 13/07/2006 chinaceae angustifoliae radix chinaceae pallidae radix 13/07/2006 chinaceae pallidae radix chinaceae purpureae herba 23/11/ chinaceae purpureae herba 1823 chinaceae purpureae herbae succus expressus et confirmatus sine ethanolo 2894 (in prep.) chinaceae 1 MA//494079/2007 Page 12/33

13 A B C D F G H I J K Ph. ur. SCOP purpureae herbae succus expressus et ethanolo confirmatus 2282 (in prep.) chinacea purpurea planta tota chinaceae purpureae radix chinaceae purpureae herba 1823 chinaceae purpureae radix /07/2006 chinaceae purpureae radix 1824 () () (1) (1) cliptae herba NL cliptae herba (6) (11/17) 2564 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 13/07/2006 quiseti herba () MA//494079/2007 Page 13/33

14 A B C D F G H I J K Ph. ur. SCOP schscholziae herba cum flore (05/06) /11/2011 schscholzia herba 3088 (in prep.) ucalypti aetheroleum H 07/09/2007 ucalypti aetheroleum 390 () 2 6 (7) ucalypti folium H 07/09/2007 ucalypti folium 1320 () 2 5 (7) () uphrasiae 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/ Foeniculi amari fructus 824 () 3 1 Foeniculi amari fructus 23/11/ Foeniculi amari () () ( 3 ) (1) () aetheroleum fructus () aetheroleum 1826 MA//494079/2007 Page 14/33

15 A B C D F G H I J K Ph. ur. SCOP 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 Gentianae radix 07/09/2007 Gentianae radix () Ginkgo bilobae folium L 07/09/2007 Ginkgonis folium 1 MA//494079/2007 Page 15/33

16 A B C D F G H I J K Ph. ur. SCOP 1828 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 Hamamelidis folium 23/11/ Hamamelidis folium 909 () 2 2 Hamamelidis folium et cortex aut ramunculus destillatum Hamamelidis aqua 23/11/ Hamamelidis aqua 2533 (deleted) () 2 Harpagophyti radix 23/11/ Harpagophyti radix 1095 Hederae helicis folium 07/09/2007 Hederae folium MA//494079/2007 Page 16/33

17 A B C D F G H I J K Ph. ur. SCOP Helichrysi flos PL 28/01/2014 Helichrysi flos (07/13) 3089 (in prep.) Herniariae herba AT/S (11/17) 30/01/2018 Hippocastani cortex 06/05/2010 Hippocastani cortex 2945 (in prep.) Hippocastani semen 07/09/2006 Hippocastani semen 1830 Hyoscyami herba 6 Hyoscyami folium 225 (deleted) Hyoscyami pulvis normatus 226 (deleted) () (2) () 2 () () (5) (4) () Hyperici herba 26/10/2006 Hyperici herba 1438 Hyperici oleum Hyperici herba () () () ( 2 ) () 2 (2) () Imperatoria ostruthium rhizoma Iridis rhizoma () 6 November 2012: cancellation of assessment work MA//494079/2007 Page 17/33

18 A B C D F G H I J K Ph. ur. SCOP Iris germanica rhizoma Juglandis folium M 10/01/2008 Juglandis folium 2946 (in prep.) 2 () Juniperi aetheroleum 17/09/2009 Juniperi aetheroleum 1832 Juniperi pseudo-fructus 06/03/2008 Juniperi galbulus 1532 Juniperi aetheroleum 1832 () () () (3) 3 Juniperus communis FR summitates 7 (07/13) 28/01/2014 Juniperi galbulus 1532 Juniperi aetheroleum 1832 () () (3) Lavandulae aetheroleum 15/01/2009 Lavandulae () () 3 (10/08) aetheroleum 1338 Lavandulae flos 15/01/2009 Lavandulae flos Leonuri cardiacae herba Company 17/09/2009 Leonuri cardiacae () (08/09) herba 1833 Leonuri herba 2785 (in prep.) 7 July 2015: cancellation of assessment work MA//494079/2007 Page 18/33

19 A B C D F G H I J K Ph. ur. SCOP 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 29/09/2015 Malvae sylvestris () (09/15) flos 1541 Malvae folium AT 29/09/2015 Malvae folium () () (09/15) 2391 Marrubii herba L 07/09/2007 Marrubii herba MA//494079/2007 Page 19/33

20 A B C D F G H I J K Ph. ur. SCOP 1835 Mate folium 07/09/2007 Mate folium 2678 Matricariae aetheroleum 07/09/2007 Matricarieae aetheroleum 1836 Matricariae flos 07/09/2007 Matricariae flos 404 () () () (1) 1 Melaleucae alternifoliae H 06/11/2008 Melaleucae 2 aetheroleum aetheroleum 1837 Meliloti herba 23/11/ Meliloti herba 2120 Melissae folium 23/11/ Melissae folium Menthae piperitae 23/11/ Menthae piperitae () 2 () aetheroleum aetheroleum 405 Menthae arvensis aetheroleum partim mentholum depletum 1838 Menthae piperitae folium 23/11/ Menthae piperitae folium () MA//494079/2007 Page 20/33

21 A B C D F G H I J K Ph. ur. SCOP Menthae arvensis aetheroleum partim mentholum depletum 1838 Menyanthidis trifoliatae PL 30/01/2018 Menyanthidis folium (10/17) trifoliatae folium 1605 Mercurialis perennis planta tota Millefolii flos 10/01/2008 Millefolii herba 1382 Millefolii herba 10/01/2008 Millefolii herba 1382 () () ( 4 ) () 4 (5) () (5) () Myrrha (Commiphora molmol) 06/10/2008 Myrrha (1) (3) Myrtilli folium 8 M 16/07/2009 Myrtilli fructus () (4) siccus 1588 Myrtilli fructus recens 1602 Myrtilli fructus siccus H 10/01/2008 Myrtilli fructus siccus November 2014: Cancellation of assessment work MA//494079/2007 Page 21/33

22 A B C D F G H I J K Ph. ur. SCOP Myrtilli fructus recens H 01/07/2014 Myrtilli fructus recens 1602 () 4 Ocimi sancti folium AYUSH (08/08) Oenotherae biennis oleum 06/11/2008 Oenotherae oleum raffinatum 2104 Oleae folium 31/10/2008 Oleae folium (4) 2 (5) Ononidis radix 24/01/2012 Ononidis radix 1879 Onopordon acanthium flos Origani dictamni herba 12/07/2011 (Origani herba 1880) Origanum majoranae (Origani herba () fructus 1880) Origanum majoranae herba (07/13) 28/01/2014 (Origani herba 1880) Orthosiphonis folium 10/01/2008 Orthosiphonis folium 1229 Paeoniae radix (07/13) 28/01/2014 Paeoniae radix alba MA//494079/2007 Page 22/33

23 A B C D F G H I J K Ph. ur. SCOP Paeoniae radix rubra 2425 Passiflorae herba 23/11/ Passiflorae herba Paulliniae semen DQM 31/03/2011 Guaranae semen (=Guaranae semen) (03/11) 2669 Pelargonii radix L 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 D (05/15) 05/05/ Piperis nigri fructus Piperis fructus 2477 Piperis longi fructus Pistacia lentiscus, resinum (Mastix) (07/13) 28/01/2014 Mastix Plantaginis lanceolatae 07/09/2007 Plantaginis () 6 () MA//494079/2007 Page 23/33

24 A B C D F G H I J K Ph. ur. SCOP folium lanceolatae folium 1884 Plantaginis ovatae semen 23/03/ Plantaginis ovatae semen (3) () Plantaginis ovatae seminis 23/03/ Plantaginis ovatae 3 () tegumentum seminis (1) tegumentum 1334 Platycodi radix Platycodonis radix Polygalae radix 9 Polygalae radix 2 (= Senegae radix) 202 Polygoni avicularis herba PL 28/01/2014 Polygoni (07/13) avicularis herba 1885 Polypodii rhizoma 08/03/2007 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 1886 () 2 9 September 2007: Cancellation of assessment work MA//494079/2007 Page 24/33

25 A B C D F G H I J K Ph. ur. SCOP Pruni spinosae flos 10 M Pruni spinosae fructus Pruni spinosae summitates 7 M () Psyllii semen 23/03/ Psyllii semen 858 Pueraria lobatae radix NL Puerariae lobatae (6) (11/17) radix 2434 Quercus cortex 10/01/2008 Quercus cortex 1887 (4) Rauwolfiae radix Rehmannia radix NL Rehmanniae radix (in combination: (11/17) 2569 (in prep.) Rehmannia 6 - Liu wei di huang wan ) Resina laricis (see Terebinthinae laricina) Rhamni purshianae cortex 23/11/ Rhamni purshianae cortex March 2012: Cancellation of assessment work MA//494079/2007 Page 25/33

26 A B C D F G H I J K Ph. ur. SCOP Rhei radix 23/11/ Rhei radix Rhodiolae roseae rhizoma H 16/07/2009 Rhodiolae roseae () et radix rhizoma et radix 2893 (in prep.) Ribis nigri folium 23/11/ Ribis nigri folium 2528 Ricini oleum PL 28/01/2014 Ricini oleum 4 (1) (07/13) virginale 0051 (3) Ricini oleum raffinatum 2367 Ricini oleum hydrogenatum 1497 Rosae aetheroleum 11 Rosae aetheroleum 3006 (in prep.) () (3) () Rosae flos 12/07/2011 Rosae flos 2949 (in prep.) Rosmarini aetheroleum 15/01/2009 Rosmarini aetheroleum 1846 Rosmarini folium 07/09/2007 Rosmarini folium () () () () March 2013: Cancellation of assessment work MA//494079/2007 Page 26/33

27 A B C D F G H I J K Ph. ur. SCOP Rubi idaei folium 13/09/2011 Rubi idaei folium 2950 (in prep.) Rusci aculeati rhizoma 13/07/2006 Rusci rhizoma 1847 () Sabalis serrulatae fructus L 07/09/2007 Sabalis serrulatae 2 (Serenoae repentis fructus) fructus 1848 Saccharomyces cerevisiae/ S. boulardii D (07/13) 28/01/2014 Salix sp. cortex 23/11/ Salicis cortex 1583 Salix sp. folium Salicis cortex (6) () () () (4) 6 Salviae miltiorrhizae radix NL 30/01/2018 Salviae et rhizoma (11/17) 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 ) MA//494079/2007 Page 27/33

28 A B C D F G H I J K Ph. ur. SCOP Salviae officinalis folium 08/03/2007 Salviae officinalis folium 1370 Salviae trilobae folium (07/13) 28/01/2014 Salviae trilobae folium 1561 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 1 (1) 1 () angustifoliae 208 () Sennae fructus acutifoliae 207 Sideritis herba (07/13) 28/01/2014 Siegesbeckia orientalis NL herba (11/17) Silybi mariani fructus M 11/03/2010 Silybi mariani 2 2 (Cardui mariae fructus) fructus 1860 Sisymbrii officinalis herba H 27/01/2011 Sisymbrii MA//494079/2007 Page 28/33

29 A B C D F G H I J K Ph. ur. SCOP (rysimi officinalis herba) officinalis herba 2942 (in prep.) Solani dulcamarae stipites L 06/03/2008 Solidaginis virgaureae herba 23/11/ Solidaginis virgaureae herba 1893 Solidaginis herba 1892 () Species amarae Species digestivae or Species stomachicae Species diureticae Species pectorales Species sedativae AT/D (11/16) AT/D (11/16) AT (11/15) SK (10/17) AT/D (11/16) 29/01/ /01/ /11/ /01/2017 Storax/ Benzoe tincture Benzoe sumatranus 1814 Benzoe MA//494079/2007 Page 29/33

30 A B C D F G H I J K Ph. ur. SCOP tonkinensis 2158 Symphyti radix 08/05/2008 Tanaceti parthenii herba 08/05/2008 Tanaceti parthenii herba 1516 Taraxaci folium 06/03/2008 Taraxaci officinalis herba cum radice 1851 Taraxaci officinalis radix () ( 3 ) () () Taraxaci radix cum herba 07/09/2007 Taraxaci () () 3 () (= Taraxacum officinale officinalis herba planta tota) cum radice 1851 Taraxaci officinalis radix 1852 Terebinthinae laricina 12 Terebinthinae (Resina laricis) aetheroleum 1627 Thymi aetheroleum 07/09/2007 Thymi typo thymolo aetheroleum 1374 () () () ( 1 ) () Thymi herba 23/11/ Thymi herba May 2010: Cancellation of assessment work MA//494079/2007 Page 30/33

31 A B C D F G H I J K Ph. ur. SCOP Thymi herba/primulae radix fixed combination 07/09/2007 Thymi herba 865 Primulae radix 1364 Tiliae flos Tiliae tomentosae flos H L 11/03/2010 Tiliae flos /03/2010 Tiliae flos 957 () ( N I S ) Tormentillae rhizoma 03/07/2008 Tormentillae rhizoma 1478 Tribulus terrestris herba Trigonellae foenugraeci semen (Foenugraeci semen ) Uncariae tomentosae cortex CZ (11/17) 10/01/2008 Trigonellae foenugraeci semen /07/2010 Uncariae tomentosa cortex 2530 (in prep.) Urticae dioica flos Urticae folium 1897 Urticae radix () () () ( 2 ) () MA//494079/2007 Page 31/33

32 A B C D F G H I J K Ph. ur. SCOP 2538 Urticae folium 23/11/ Urticae folium 1897 Urticae herba 23/11/ Urticae folium 1897 Urticae radix 2538 Urticae radix 23/11/ Urticae radix 2538 Uvae ursi folium 23/11/ Uvae ursi folium 1054 ( 2 ) () ( 2 ) () 2 2 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/ Lupuli flos 31/10/2007 Valerianae radix 453 MA//494079/2007 Page 32/33

33 A B C D F G H I J K Ph. ur. SCOP fixed combination Lupuli flos 1222 Verbasci flos 08/03/2007 Verbasci flos 1853 Verbenae citriodorae folium S 30/01/2018 Verbenae (11/17) 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 12/07/2011 Withaniae 4 1 (08/08) somniferae radix 2746 (in prep.) Zingiberis rhizoma 23/11/ Zingiberis rhizoma (2) 8 MA//494079/2007 Page 33/33