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Regulatory and procedural guideline: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials, adopted

Regulatory and procedural guideline: Initial notices for parallel distribution – June 2010

News and Press Releases EMA and US FDA seek potential candidate companies for joint GMP inspection programme

News and Press Releases European Medicines Agency starts review of Pandemrix

Regulatory and procedural guideline: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials, adopted

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admin @ September 3, 2010

Regulatory and procedural guideline: Initial notices for parallel distribution – June 2010

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admin @ September 3, 2010

News and Press Releases EMA and US FDA seek potential candidate companies for joint GMP inspection programme

Posted in: European Medicines Agency | Comments (0)

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admin @ September 3, 2010

News and Press Releases European Medicines Agency starts review of Pandemrix

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Agency is investigating whether there is a link between vaccine and cases of narcolepsy
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admin @ September 3, 2010

News and Press Releases CHMP meeting on 8 September 2010 to discuss Avandia and Pandemrix

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The Committee for Medicinal Products for Human Use (CHMP) is meeting on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim.
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admin @ September 3, 2010

Final assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

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Overview of comments received on community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

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admin @ September 3, 2010

Final opinion of the HMPC on a community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

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admin @ September 3, 2010

Final list of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos, adopted

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admin @ September 3, 2010

Draft community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum, draft: consultation open

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admin @ September 3, 2010

Draft list of references supporting the assessment of Cinnamomum verum J. S. Presl, (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum: Cinnamomi cortex and Cinnamomi corticis aetheroleum (Cinnamon and Cinnamon bark oil), draft

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admin @ September 3, 2010

Draft assessment report on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum, draft

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admin @ September 3, 2010

Draft community herbal monograph on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex, draft: consultation open

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admin @ September 3, 2010

Draft Assessment report on Arctostaphylos uvae ursi (L.) Spreng, folium , draft

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admin @ September 3, 2010

Draft Assessment report on Arctostaphylos uvae ursi (L.) Spreng, folium, draft

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admin @ September 3, 2010

Draft list of references supporting the assessment of Arctostaphylos uvae ursi (L.) Spreng, folium, draft

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admin @ September 3, 2010

Draft community herbal monograph on Arctostaphylos uvae ursi (L.) Spreng, folium , draft: consultation open

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admin @ September 3, 2010

Opinion of the HMPC on a community herbal monograph on Ribes nigrum L., folium, adopted

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admin @ September 3, 2010

Overview of comments received on Community herbal monograph on Ribes nigrum L., folium

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admin @ September 3, 2010

Final: List of references supporting the assessment of Ribes nigrum L., folium; Ribis nigri folium; (blackcurrant leaf)

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admin @ September 3, 2010

Final: Assessment report on Ribes nigrum L., folium

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admin @ September 3, 2010

Draft assessment report on Trigonella foenum-graecum L., semen, draft: consultation open

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admin @ September 3, 2010

Draft list of references supporting the assessment of Trigonella foenum-graecum L., semen, draft: consultation open

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admin @ September 3, 2010

Draft list of references supporting the assessment of Potentilla erecta (L.) Raeusch., rhizome, draft

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admin @ September 3, 2010

Draft list of references supporting the assessment of Juniperus communis L., aetheroleum, draft

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admin @ September 3, 2010

Draft list of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip., draft

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admin @ September 3, 2010

Draft list of references supporting the assessment of Viola tricolor L., draft: consultation closed

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admin @ September 3, 2010

Draft assessment report on Leonurus cardiaca L., herba, draft

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admin @ September 3, 2010

Draft list of references supporting the assessment of Leonurus cardiaca L., herba Leonuri cardiacae herba, (motherwort), draft

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admin @ September 3, 2010

Overview of comments received on community herbal monograph on Curcuma longa L., rhizoma, adopted

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admin @ September 3, 2010

Overview of comments received on ‘Community herbal monograph on Primula veris L., Primula elatior (L.) Hill, flos’

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admin @ September 3, 2010

Opinion of the committee on herbal medicinal products on a community herbal monograph on Primula veris L., Primula elatior (L.) Hill, flos’, adopted

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admin @ September 3, 2010

Final list of references supporting the assessment of Primulae flos Primula veris L. and Primula elatior (L.) Hill (primula flower)

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admin @ September 3, 2010

Final assessment report on Primula veris L., and Primula elatior (L.) Hill, flos’, adopted

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admin @ September 3, 2010

Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hamamelis virginiana L., folium, adopted

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admin @ September 3, 2010

Draft community list entry on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum, draft: consultation closed

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admin @ September 3, 2010

Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum, adopted

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admin @ September 3, 2010

Overview of comments received on community herbal monograph on Hamamelis virginiana L., folium

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admin @ September 3, 2010

Assessment report on hamamelis virginiana l., cortex hamamelis virginiana l., folium hamamelis virginiana l., folium et cortex aut ramunculus destillatum, adopted

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admin @ September 3, 2010

Final list of references supporting the assessment report on: Hamamelidis cortex, Hamamelidis folium, Hamamelidis folium et cortex aut ramunculus destillatum; Hamamelis virginiana L. (hamamelis bark, hamamelis leaf, hamamelis leaf and bark or twigs distillate)

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admin @ September 3, 2010

Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hamamelis virginiana L., cortex, adopted

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admin @ September 3, 2010

Call for submission of scientific data on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols), fructus

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admin @ September 3, 2010

Call for submission of scientific data on Fumaria officinalis L., herba Fumariae herba (fumitory)

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admin @ September 3, 2010

Call for submission of scientific data on Silybum marianum (L.) Gaertner, fructus: Silybi mariani fructus (milkthistle fruit), draft: consultation closed

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admin @ September 3, 2010

Call for submission of scientific data on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, flos (lime flower)

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admin @ September 3, 2010

Grindelia robusta Nutt., G. squarrosa Dunal, G. humilis Hook. et Arn., G. camporum Greene, herba

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admin @ September 3, 2010

Call for submission of scientific data on Tilia tomentosa Moench, flos (silver lime)

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admin @ September 3, 2010

Call for submission of scientific data on Allium cepa L., bulbus Allii cepae bulbus (onion)

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admin @ September 3, 2010

List of references supporting the HMPC assessment report on Gentianae radix, Gentiana lutea L., radix (gentian root), adopted

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admin @ September 3, 2010

Draft list of references for assessment of Quercus robur L., Quercus petrea.(Matt.) Liebl. and Quercus pubescens Willd., Quercus cortex (oak bark), draft

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admin @ September 3, 2010

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