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Monografías y otros documentos sobre preparados fitoterápicos publicados recientemente por la Agencia Europea del Medicamento (EMA)

17/10/2017

Los datos de estas publicaciones, se han actualizado en las monografías correspondientes del Vademécum de Fitoterapia.


2017

- Draft European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/441766/2017. Publicación: 8/12/2017.

- Draft assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. London: London: EMA. Doc. Ref.: EMA/HMPC/441766/2017. Publicación: 8/12/2017.

- Draft list of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/441802/2017. Publicación: 8/12/2017.

- Draft European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/329755/2017. Publicación: 8/12/2017.

- Draft assessment report on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/749518/2016. Publicación: 8/12/2017.

- Draft list of references supporting the assessment of Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1. London: EMA. Doc. Ref.: EMA/434955/2017. Publicación: 8/12/2017.

- Draft European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1. Doc. Ref.: EMA/HMPC/228761/2016. London: EMA. Published: 12/10/2017.

- Draft assessment report on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1. Doc. Ref.: EMA/HMPC/228759/2016. London: EMA. Published: 12/10/2017.

- Final European Union herbal monograph on Artemisia absinthium L., herba - Revision 1. Doc. Ref.: EMA/HMPC/751490/2016. London: EMA. Adopted: 05/10/2017.

- Final assessment report on Artemisia absinthium L., herba - Revision 1. Doc. Ref.: EMA/HMPC/751484/2016. London: EMA. Adopted: 05/10/2017.

- Final list of references supporting the assessment of Artemisia absinthium L., herba - Revision 1. Doc. Ref.: EMA/HMPC/186849/2017. London: EMA. Adopted: 05/10/2017.

- Final European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex. London: EMA. Doc. Ref.: EMA/HMPC/680626/2013. Published: 1/9/2017.

- Final assessment report on Prunus africana (Hook f.) Kalkm., cortex. London: EMA. Doc. Ref.: EMA/HMPC/680624/2013. Published: 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. London: EMA. Doc. Ref.: EMEA/HMPC/32116/2005 Rev.1. Adopted: 22/8/2017.

- European Union herbal monograph on Echinacea purpurea (L.) Moench, radix. London: EMA. Doc. Ref.: EMA/HMPC/424583/2016. Published: 11/8/2017.

- Final assessment report on Echinacea purpurea (L.) Moench, radix – Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/424584/2016. Published: 11/8/2017.

- European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma. Draft-Revision. London: EMA. Doc. Ref.: EMA/HMPC/48745/2017. Published: 4/8/2017.

Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma. Draft-Revision. London: EMA. Doc. Ref.: EMA/HMPC/48744/2017. Published: 4/8/2017.

European Union herbal monograph on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Doc. Ref.: EMA/HMPC/80630/2016. Adopted: 31 January 2017.

List of references supporting the assessment of Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Doc. Ref.: EMA/HMPC/80629/2016. Adopted: 31 January 2017.

Assessment report on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex. Doc. Ref.: EMA/HMPC/80628/2016. Adopted: 31 January 2017.

- Overview and recommendations for the uses of herbal mendicinal products in the pediatric population. Doc. Ref.: EMA/HMPC/228356/2012. Adopted 02/02/2016.

- Assessment report on Paeonia lactiflora Pall. and/or Paeonia veitchii  Lynch, radix (Paeoniae radix rubra). Doc. Ref:  EMA/HMPC/762953/2015. Adopted: 31 January 2017.

European Union herbal monograph on Melilotus officinalis (L.) Lam., herba. Draft. Doc. Ref.: EMA/HMPC/44166/2016. London: EMA. Adopted on: 28 March 2017.

Assessment report on Melilotus officinalis (L.) Lam., herba. Draft. Doc. Ref.: EMA/HMPC/44165/2016. London: EMA. Adopted on: 28 March 2017.

European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium. Draft. Doc. Ref.: EMA/HMPC/750269/2016. London: EMA. Adopted on: 28 March 2017.

Assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium. Draft. Doc. Ref.: EMA/HMPC/750269/2016. London: EMA. Adopted on: 28 March 2017.

- European Union herbal monograph on Ribes nigrum L., folium Draft. London: EMA. Doc Ref: EMA/HMPC/745353/2016. Adopted: 28/2/2017.

- European Union herbal monograph on Mentha x piperita L., folium. Draft. London: EMA. Doc Ref: EMA/HMPC/572705/2014. Adopted: 23/2/2017.

European Union herbal monograph on Peumus boldus Molina, folium. London: EMA. Doc. Ref.: EMA/HMPC/453725/2016. Adopted: 22 November 2016.  Updated: 12/01/2017.

- Final assessment report on Peumus boldus Molina, folium. London: EMA. Doc. Ref.: EMA/HMPC/453726/2016. Adopted: 22 November 2016. Updated: 12/01/2017.

- Final list of references supporting the assessment of Peumus boldus Molina, folium. London: EMA. Doc. Ref.: EMA/HMPC/747075/2016. Adopted: 22 November 2016. Updated: 12/01/2017.

- Regulatory questions and answers on herbal medicinal products. London: EMA. Doc. Ref.: EMA/HMPC/345132/2010 Rev.3. Adopted: 20 September 2016. Last updated: 06/01/2017.

2016

-Herbal medicine: summary for the public. Marjoram (Origanum majorana L., herba). London: EMA. Doc. Ref.: EMA/653011/2016. Adopted: 22/12/2016.

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: 22/11/2016.

Herbal medicine: summary for the public. Marshmallow root (Althaea officinalis L., radix). London: EMA. Doc. Ref.: EMA/570566/2016. Adopted: 22/11/2016.

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: 22/11/2016.

Herbal medicine: summary for the public. Arnica flower (Arnica montana L., flos). London: EMA. Doc. Ref.: EMA/654173/2016. Adopted: 22/11/2016.

Herbal medicine: summary for the public. Marjoram (Origanum majorana L., herba). London: EMA. Doc. Ref.: EMA/653011/2016. Adopted: 22/11/2016.

Herbal medicine: summary for the public. Javanese turmeric (Curcuma xanthorrhiza Roxb., C. xanthorrhiza D. Dietrich, rhizoma). London: EMA. Doc. Ref.: EMA/654803/2016. Adopted: 22/11/2016.

- 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.

Cita publicaciones
Editores
Bernat Vanaclocha i Vanaclocha
Médico, Colegiado Nº 464610887
Director de Cita Publicaciones y Documentación S.L.

Salvador Cañigueral Folcarà
Unitat de Farmacologia i Farmacognòsia
Facultat de Farmàcia, Universitat de Barcelona