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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
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 Page 2/33
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)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 3/33
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 × × × (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 4/33
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
(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 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 5/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 6/33
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
(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 × × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 7/33
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
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)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 8/33
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
(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 (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 9/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 10/33
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
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
× × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 11/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 12/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 13/33
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
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 (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 14/33
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
(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) (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 15/33
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
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 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 16/33
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
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
× × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 17/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 18/33
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
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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 19/33
A B C D E F G H I J K
Herbal substances Total priority 2005
Proposal after
2005 by IPs/NCA (date)
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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 × × ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 20/33
A B C D E F G H I J K
Herbal substances Total priority 2005
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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
(×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 21/33
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Herbal substances Total priority 2005
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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
10/01/2008 Myrtilli fructus
siccus 1588
× × × 4
8 November 2014: Cancellation of assessment work
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 22/33
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Herbal substances Total priority 2005
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a b c
(09/10)
Myrtilli fructus recens ● H
AESGP
(09/10)
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
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 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 23/33
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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 (×)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 24/33
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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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 25/33
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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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 26/33
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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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 27/33
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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 )
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 28/33
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Herbal substances Total priority 2005
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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 ×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 29/33
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(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
×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 30/33
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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
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 31/33
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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)
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 32/33
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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
×
Inventory of herbal substances for assessment EMA/HMPC/494079/2007 Page 33/33
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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 ×