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Monografías y otros documentos sobre drogas vegetales

28/01/2019 | Agencia Europea del Medicamento (EMA)

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


2019

Final European Union herbal monograph on Curcuma longa L., rhizoma - Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/329755/2017. Publication: 24/1/2019.

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. London: EMA. Doc. Ref.: EMA/HMPC/294187/2013. Adopted: 19/9/2018.

Final assessment report on Silybum marianum (L.) Gaertn., fructus. London: EMA. Doc. Ref.: EMA/HMPC/294188/2013. Adopted: 19/9/2018.

Final list of references supporting the assessment of Silybum marianum (L.) Gaertn., fructus. Draft. London: EMA. Doc. Ref.: EMA/HMPC/278220/2015. Adopted: 19/9/2018.

Final European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1. Doc. Ref.: EMA/HMPC/444244/2015. Adopted: 20/8/2018.

Final assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1. Doc. Ref.:EMA/HMPC/444251/2015. Adopted: 20/8/2018.

Final list of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1. Doc. Ref.: EMA/HMPC/444243/2015. Adopted: 20/8/2018.

Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3. Doc. Ref.: EMA/HMPC/201116/2005. Adopted: 15/8/2018.

Overview of recommendations for the uses of herbal medicinal products in the paediatric population. Doc. Ref.: EMA/HMPC/228356/2012, Adopted: 24/7/2018.

Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2.  Doc. Ref.: EMA/HMPC/124695/2011. Adopted: 14/8/2018.

Final European Union herbal monograph on Echinacea pallida (Nutt.) Nutt., radix - Revision 1. Doc. Ref.:EMA/HMPC/737380/2018. Adopted: 14/8/2018.

Final assessment report on Echinacea pallida (Nutt.) Nutt., radix - Revision 1. Doc. Ref.: EMA/HMPC/737379/2017. Adopted: 14/8/2018.

Final list of references supporting the assessment of Echinacea pallida (Nutt.) Nutt., radix - Revision 1. Doc. Ref.: EMA/HMPC/737378/2018. Adopted: 14/8/2018.

Final European Union herbal monograph on Hedera helix L., folium - Revision 2. Doc. Ref.: EMA/HMPC/325716/2017. Adopted: 13/8/2018.

Final assessment report on Hedera helix L., folium - Revision 2. Doc. Ref.: EMA/HMPC/325715/2017. Adopted: 13/8/2018.

Final list of references supporting the assessment of Hedera helix L., folium - Revision 2. Doc. Ref.: EMA/HMPC/325719/2017. Adopted: 13/8/2018.

Final assessment report on Glycine max (L.) Merr., semen - First version. Doc. Ref.: EMA/HMPC/461813/2016. Adopted: 31/7/2018.

Assessment report on Cimicifuga racemosa (L.) Nutt., rhizoma. London: EMA. Doc. Ref.: EMA/HMPC/48744/2017. Adopted: 3/7/2018.

European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma. London: EMA. Doc. Ref.: EMA/HMPC/48745/2017. Adopted: 3/7/2018.

 Final list of references supporting the assessment of Cimicifuga racemosa (L.) Nutt., rhizoma - Revision 1. EMA/HMPC/193919/2017. Adopted: 3/7/2018.

Draft assessment report on Malva sylvestris L. and/or Malva neglecta Wallr., folium and Malva sylvestris L., flos - First version. London: EMA. Doc. Ref.: EMA/HMPC/749518 . Adopted: 2/7/2018.

Draft European Union herbal monograph on Malva sylvestris L. and/or Malva neglecta Wallr., folium - First version. London: EMA. Doc. Ref.: EMA/HMPC/749510/2016. Adopted: 2/7/2018.

Final assessment report on Sambucus nigra L., flos - Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/611504/2016. Adopted: 27/6/2018.

Final European Union herbal monograph on Sambucus nigra L., flos - Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/611512/2016. Adopted: 27/6/2018.

Final assessment report on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. London: EMA. Doc. Ref.: EMA/HMPC/611531/2016. Adopted: 22/6/2018.

Final European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. London: EMA. Doc. Ref.: EMA/HMPC/611537/2016. Adopted: 22/6/2018.

Final assessment report on Calendula officinalis L., flos - Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/603409/2017. Adopted: 14/6/2018.

Final European Union herbal monograph on Calendula officinalis L., flos - Revision 1. London: EMA. Doc. Ref.: EMA/HMPC/437450/2017. Adopted: 22/6/2018.

Final Community herbal monograph on Panax ginseng C.A. Meyer, radix. London: EMA. Doc. Ref.: EMA/HMPC/321233/2012. Rev 1. Adopted: 26/4/2018.

Final European Union herbal monograph on Melilotus officinalis (L.) Lam., herba. Doc. Ref.: EMA/HMPC/44166/2016. London: EMA. Published: 23/4/2018.

Final assessment report on Melilotus officinalis (L.) Lam., herba. Doc. Ref.: EMA/HMPC/44165/2016. London: EMA. Published: 23/4/2018.

Final list of references supporting the assessment of Melilotus officinalis (L.) Lam., herba. Doc. Ref.: EMA/HMPC/350533/2016. London: EMA. Published: 23/4/2018.

European Union herbal monograph on Ruscus aculeatus L. rhizoma Draft. London: EMA. Doc. Ref.: EMA/188804/2017. Published: 08/03/2018.

Draft assessment report on Ruscus aculeatus L. rhizome - Revision 1 London: EMA. Doc. Ref.: EMA/188805/2017. Published: 08/03/2018.

Draft list of references supporting the assessment of Ruscus aculeatus L. rhizoma - Revision 1. London: EMA. Doc. Ref.: EMA/188806/2017. Published: 08/03/2018.

Final European Union herbal monograph on Vitis vinifera L., folium - First version. Published: 5/1/2018.

Final assessment report on Vitis vinifera L., folium - First version. Published: 5/1/2018.

Final list of references supporting the assessment of Vitis vinifera L., folium - First version. Published: 5/1/2018.

2017

- Final European Union herbal monograph on Ribes nigrum L., folium - revision 1. Adopted: 19/12/2017.

- Final assessment report on Ribes nigrum L., folium - revision 1. London: EMA. Doc Ref: EMA/HMPC/745347/2016. Adopted: 19/12/2017.

- Final list of references supporting the assessment of Ribes nigrum L., folium - revision 1. London: EMA. Doc Ref: EMA/HMPC/745349/2016. Adopted: 19/12/2017.

- 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