Monografías y otros documentos de la Agencia Europea del Medicamento (EMA) sobre drogas vegetales: publicaciones recientes

Actualizada: 03/06/2020

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Publicadas en 2020

• Herbal medicinal product: Aloysiae folium (updated). Draft under discussion. Publicación: 29/05/2020
• Combination Herbal medicinal product: Species sedativae (updated). Draft under discussion. Publicación: 29/05/2020
• Combination Herbal medicinal product: Species amarae (updated). Draft under discussion. Publicación: 28/05/2020
• Herbal medicinal product: Pistacia lentiscus, resinum (mastic) (updated). Assessment finalised. Publicación: 05/05/2020
• Herbal medicinal product: Allii sativi bulbus. Assessment finalised. Publicación: 28/04/2020
• Herbal medicinal product: Hippocastani semen (updated). Assessment finalised. Publicación: 23/4/2020
• Herbal medicinal product: Absinthii herba (updated). Assessment finalised. Publicación: 8/4/2020
• Herbal medicinal product: Taraxaci radix cum herba (updated). Assessment finalised. Publicación: 8/4/2020
• Herbal medicinal product: Arctii radix (updated). Assessment finalised. Publicación: 3/4/2020
• Herbal medicinal product: Sennae folium (updated). Assessment finalised. Publicación: 2/4/2020
• Herbal medicinal product: Sennae fructus (updated). Assessment finalised. Publicación: 2/4/2020
• Herbal medicinal product: Agni casti fructus. Assessment finalised. Publicación: 25/2/2020
• Herbal medicinal product: Combination: Valerianae radix and Lupuli flos (updated), Assessment finalised. Publicación: 5/2/2020
• Herbal medicinal product: Taraxaci folium (updated), Assessment finalised. Publicación: 3/2/2020
• Herbal medicinal product: Agropyri repentis rhizoma (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Caryophylii floris aetheroleum (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Carvi fructus (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Carvi aetheroleum (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Zingiberis rhizoma (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Chamomillae romanae flos (updated),  Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Colae semen (updated), Assessment finalised. Publicación: 31/1/2020
• Herbal medicinal product: Pelargonii radix (updated), Assessment finalised. Publicación: 31/01/2020
• Herbal medicinal product: Millefolii herba (updated), Assessment finalised. Publicación: 31/01/2020

Publicadas en 2019

• Herbal medicinal product: Hamamelidis folium, Assessment finalised. Publicación: 09/12/2019
• Herbal medicinal product: Hamamelidis cortex, Assessment finalised. Publicación: 04/12/2019
• Herbal medicinal product: Hamamelidis folium et cortex aut ramunculus destillatum, Assessment finalised. Publicación: 04/12/2019
• Herbal medicinal product: Frangulae cortex. Assessment finalised. Publicación: 4/12/2019
• Herbal medicinal product: Thymi aetheroleum, Assessment finalised. Publicación: 15/10/2019
• Herbal medicinal product: Rhamni purshianae cortex, Assessment finalised. Publicación: 15/10/2019
• Herbal medicinal product: Tanaceti parthenii herba, Assessment finalised. Publicación: 15/10/2019
• Herbal medicinal product: Rhei radix, Assessment finalised. Publicación: 15/10/2019
• Herbal medicinal product: Avenae fructus, Assessment finalised, Publicación: 23/08/2019
• Herbal medicinal product: Avenae herba, Assessment finalised, Publicación: 23/08/2019
• Herbal medicinal product: Myrrha, gummi-resina, Assessment finalised, Publicación: 23/08/2019
• Herbal medicinal product: Bursae pastoris herba, Assessment finalised, Publicación: 23/08/2019
• Herbal medicinal product: Polypodii rhizoma, Assessment finalised, Publicación: 22/08/2019
• Herbal medicinal product: Phaseoli fructus (sine semine), Assessment finalised, Publicación: 22/08/2019
• Herbal medicinal product: Rusci aculeati rhizoma, Draft under discussion, Publicación: 22/08/2019
• Herbal medicinal product: Millefolii flos, Assessment finalised, Publicación: 22/08/2019
• Herbal medicinal product: Leonuri cardiacae herba, Assessment finalised, Publicación: 22/08/2019
• Medicinal product: Gentianae radix, Assessment finalised, Publicación: 22/08/2019
• Herbal medicinal product: Fragariae folium, Assessment finalised, Publicación: 22/08/2019
• Herbal medicinal product: Hippocastani semen (updated). Publicación: 18/06/2019
• Herbal medicinal product: Menthae piperitae aetheroleum. Publicación: 18/6/2019
• Herbal medicinal product: Fragariae folium. Publicación: 15/5/2019
• Herbal medicinal product: Malvae folium. Publicación: 19/3/2019
• Herbal medicinal product: Malvae flos. Publicación: 19/3/2019
• Herbal medicinal product: Cynarae folium. Publicación: 7/2/2019
• Herbal medicinal product: Curcuma longa L., rhizoma. Publicación: 24/1/2019.

Publicadas en 2018
– Final Community herbal monograph on Vitex agnus-castus L., fructus. London: EMA. Doc. Ref.: EMA/HMPC/606742/2017. Adopted: 10-10-2018.
– Assessment report on Vitex agnus-castus L., fructus. London: EMA. Doc. Ref.: EMA/HMPC/606741/2018. Adopted: 10-10-2018.
– Final list of references supporting the assessment of Vitex agnus-castus L., fructus. London: EMA. Doc. Ref.: EMA/HMPC/795807/2017. Adopted: 10-10-2018.
– Final European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus. Publicación: 19/9/2018.
– Final assessment report on Silybum marianum (L.) Gaertn., fructus. Publicación: 19/9/2018.
– Final list of references supporting the assessment of Silybum marianum (L.) Gaertn., fructus. Publicación: 19/9/2018.
– Final European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix – Revision 1. Publicación: 20/8/2018.
– Final assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix – Revision 1. Publicación: 20/8/2018.
– Final list of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix – Revision 1. Publicación: 20/8/2018.
– Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products – Revision 3. Publicación: 15/8/2018.
– HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population. Publicación: 24/7/2018.
– Final European Union herbal monograph on Echinacea pallida (Nutt.) Nutt., radix – Revision 1. Publicación: 14/8/2018.
– Final assessment report on Echinacea pallida (Nutt.) Nutt., radix – Revision 1. Publicación: 14/8/2018.
– Final list of references supporting the assessment of Echinacea pallida (Nutt.) Nutt., radix – Revision 1. Adopted: 14/8/2018.
– Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma. Publicación: 3/7/2018.
– European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma. Publicación: 3/7/2018.
– Draft assessment report on Malva sylvestris L. and/or Malva neglecta Wallr., folium and Malva sylvestris L., flos – First version. Publicación: 2/7/2018.
– Draft European Union herbal monograph on Malva sylvestris L. and/or Malva neglecta Wallr., folium – First version. Publicación: 2/7/2018.
– Final assessment report on Sambucus nigra L., flos – Revision 1. Publicación: 27/6/2018.
– Final European Union herbal monograph on Sambucus nigra L., flos – Revision 1. Publicación: 27/6/2018.
– Final assessment report on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. Publicación: 22/6/2018.
– Final European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. Publicación: 22/6/2018.
– Final assessment report on Calendula officinalis L., flos – Revision 1. Publicación: 14/6/2018.
– Final European Union herbal monograph on Calendula officinalis L., flos – Revision 1. Publicación: 22/6/2018.
– Final Community herbal monograph on Panax ginseng C.A. Meyer, radix. Publicación: 26/4/2018.
– Final European Union herbal monograph on Melilotus officinalis (L.) Lam., herba. Publicación: 23/4/2018.
– Final assessment report on Melilotus officinalis (L.) Lam., herba. Publicación: 23/4/2018.
– Final list of references supporting the assessment of Melilotus officinalis (L.) Lam., herba. Publicación: 23/4/2018.
– Final European Union herbal monograph on Vitis vinifera L., folium – First version. Publicación: 5/1/2018.
– Final assessment report on Vitis vinifera L., folium – First version. Publicación: 5/1/2018.
– Final list of references supporting the assessment of Vitis vinifera L., folium – First version. Publicación: 5/1/2018.

Publicadas en 2017
– Final European Union herbal monograph on Ribes nigrum L., folium – revision 1. Publicación: 19/12/2017.
– Final assessment report on Ribes nigrum L., folium – revision 1. Publicación: 19/12/2017.
– Final list of references supporting the assessment of Ribes nigrum L., folium – revision 1. Publicación: 19/12/2017.
– Draft European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. Publicación: 8/12/2017.
– Draft assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. Publicación: 8/12/2017.
– Draft list of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. Publicación: 8/12/2017.
– Draft European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. Publicación: 8/12/2017.
– Draft assessment report on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. Publicación: 8/12/2017.
– Draft list of references supporting the assessment of Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. Publicación: 8/12/2017.
– Draft European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1. Publicada: 12/10/2017.
– Draft assessment report on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1. Publicada: 12/10/2017.
– Final European Union herbal monograph on Artemisia absinthium L., herba – Revision 1. Adoptada: 05/10/2017.
– Final assessment report on on Artemisia absinthium L., herba – Revision 1. Aprobada: 05/10/2017.
– Final European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex. Aprobada: 1/9/2017.
– Final assessment report on Prunus africana (Hook f.) Kalkm., cortex. Publicación: 1/9/2017.
– Draft guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products – Revision 1. Publicación: 11/8/2017.
– Final European Union herbal monograph on Echinacea purpurea (L.) Moench, radix – Revision 1. Publicación: 11/8/2017.
– Final assessment report on Echinacea purpurea (L.) Moench, radix – Revision 1. Publicación: 11/8/2017.
– Draft European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome – Revision 1. Publicación: 4/8/2017.
– Draft assessment report on Cimicifuga racemosa (L.) Nutt., rhizome – Revision 1. Publicación: 4/8/2017.
European Union herbal monograph on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Aprobada: 31/01/2017.
– List of references supporting the assessment of Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Aprobada: 31/01/2017.
– Assessment report on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Aprobada: 31/01/2017.
– Overview and recommendations for the uses of herbal mendicinal products in the pediatric population. Aprobada: 26/01/2017.
– Final Assessment report on Paeonia lactiflora Pall. and/or Paeonia veitchii Lynch, radix (Paeoniae radix rubra). Aprobada: 31/01/2017.
– Draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba. Aprobada: 28/03/2017.
– Draft Assessment report on Melilotus officinalis (L.) Lam., herba. Aprobada: 28/03/2017.
– Draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium. Aprobada: 28/03/2017.
– Draft Assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium. Aprobada: 28/03/2017.
– Final European Union herbal monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus. Aprobada: 10/4/2017
– Final Assessment report on herbal monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus. Aprobada: 10/4/2017
– Draft European Union herbal monograph on Ribes nigrum L., folium. Aprobada: 28/02/2017.
– Draft European Union herbal monograph on Mentha x piperita L., folium. Aprobada: 23/02/2017.
– Final European Union herbal monograph on Glycine max (L.) Merr., oleum raffinatum. Aprobada: 03/03/2107
– Final assessment report on Glycine max (L.) Merr., oleum raffinatum. Aprobada: 03/03/2107
– Final European Union herbal monograph on Peumus boldus Molina, folium. Aprobada: 22/11/2016.  Actualizada: 12/01/2017.
– Final assessment report on Peumus boldus Molina, folium. Aprobada: 22/11/2016.  Actualizada: 12/01/2017.
– Final list of references supporting the assessment of Peumus boldus Molina, folium. Aprobada: 22/11/2016.  Actualizada: 12/01/2017.
– Regulatory questions and answers on herbal medicinal products. Aprobada: 20/09/2016. Actualizada: 06/01/2017.

Publicadas en 2016
– Herbal medicine: summary for the public. Eucalyptus oil (Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum). London: EMA. Doc. Ref.: EMA/EMA/HMPC/288003/2014. Adopted: 22 November 2016.
– Herbal medicine: summary for the public. Marshmallow root (Althaea officinalis L., radix). London: EMA. Doc. Ref.: EMA/570566/2016. Adopted: 22 November 2016.
– Herbal medicine: summary for the public. Devil’s claw root (Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix). London: EMA. Doc. Ref.: EMA/571858/2016. Adopted: 22 November 2016.
– Herbal medicine: summary for the public. Arnica flower (Arnica montana L., flos). London: EMA. Doc. Ref.: EMA/654173/2016. Adopted: 22 November 2016.
– Herbal medicine: summary for the public. Marjoram (Origanum majorana L., herba). London: EMA. Doc. Ref.: EMA/653011/2016. Adopted: 22 November 2016.
– Herbal medicine: summary for the public. Javanese turmeric (Curcuma xanthorrhiza Roxb., rhizoma). London: EMA. Doc. Ref.: EMA/654803/2016. Adopted: 22 November 2016.
– Final European Union herbal monograph on Origanum majorana L., herba. Publicada 15/11/2016
– Final European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix. Publicada: 14/11/2016
– Draft European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus. Publicada: 7/11/2016
– Final European Union herbal monograph on Althaea officinalis L., radix. Publicada: 04/11/2016
– Draft European Union herbal monograph on Species diureticae. Publicada 28/10/2016
– Final European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba. Publicada: 28/10/2016
– Draft European Union herbal monograph on Glycine max (L.) Merr., lecithin. Publicada: 27/7/2016
– Draft European Union herbal monograph on Allium sativum L., bulbus. Publicada: 25/7/2016.
– Draft European Union herbal monograph on Glycine max (L.) Merr., oleum. Publicada: 25/7/2016.
– Final European Union herbal monograph on Valeriana officinalis L., aetheroleum. Publicada: 27/4/2916.
– Final European Union herbal monograph on Crataegus spp., folium cum flore. Publicada: 17/6/2016.
– Final Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix . Publicada: 9/6/2016.
– Final European Union herbal monograph on Polygonum aviculare L., herba. Publicada: 23/5/2016.
– Final European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos. Publicada: 23/5/2016.
– Final European Union herbal monograph on Valeriana officinalis L., radix. Publicada: 23/5/2016.
– Final European Union herbal monograph on Matricaria recutita L., flos. Publicada: 5/4/2016.
– Final European Union herbal monograph on Matricaria recutita L., aetheroleum. Publicada 5/4/2016.
– Final European Union herbal monograph on Equisetum arvense L., herba. Publicada 17/3/2016.
– Final European Union herbal monograph on Ricinus communis L., oleum. Publicada: 01/03/2016.
– Draft European Union herbal monograph on Origanum majorana L., herba. Publicada: 15/02/2016.
– Draft European Union herbal monograph on Salvia officinalis L., folium. Publicada: 15/02/2016.
– European Union herbal monograph on Centaurium erythraea Rafn. s.l., herba. Publicada: 27/01/2016.
– Final European Union herbal monograph on Hedera helix L., folium. Publicada: 18/01/2016.
– Final European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus. Publicada: 14/01/2016.
– Final European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba. Publicada: 13/01/2016.

Fuente: Fitoterapia.net, 28/4/2020