Committee for Medicinal Products for Human Use

Results: 188



#Item
51Pharmaceuticals policy / Pharmaceutics / Pharmacology / Clinical research / Biologic / European Medicines Agency / Marketing authorization / Committee for Medicinal Products for Human Use / Good manufacturing practice / Pharmaceutical industry / Business / Pharmaceutical sciences

Guideline on the use of starting materials-intermediates collected from different sources in the manufacturing of biological medicinal products - for publishing

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Source URL: www.ema.europa.eu

Language: English - Date: 2013-07-21 06:43:56
52Pharmaceutical sciences / Pharmaceutics / European Medicines Agency / EMA / Validation / European Directorate for the Quality of Medicines / Committee for Medicinal Products for Human Use / Clinical trial / Clinical research / Pharmaceutical industry / Research

Regulatory acceptance of 3Rs testing methods for medicinal products – EMA perspective Dr. Sonja Beken EMA Joint Expert Group on the application of 3Rs EMA Safety Working Party

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Source URL: circabc.europa.eu

Language: English
53Biological weapons / Piperazines / Microbiology / Occupational diseases / Zoonoses / Anthrax / Doxycycline / Committee for Medicinal Products for Human Use / Pefloxacin / Medicine / Health / Biology

Microsoft Word - CTS227355798

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Source URL: www.ema.europa.eu

Language: English - Date: 2013-07-21 05:37:31
54Research / Pharmaceutical sciences / Health / European Union / Medicinal product / Committee for Medicinal Products for Human Use / Summary of Product Characteristics / Referral marketing / Directive 2001/83/EC / Clinical research / Pharmacology / Pharmaceuticals policy

CMDh RECOMMENDATION ON IMPLEMENTATION OF ARTICLE 30 DECISIONS cf. DIRECTIVE[removed]EC, AS AMENDED FOR GENERIC/HYBRID/BIOSIMILAR MEDICINAL PRODUCTS APPROVED THROUGH MRP/DCP Doc. Ref.: CMDh[removed]Revision 4, June 2010

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Source URL: www.hma.eu

Language: English - Date: 2013-08-01 09:55:16
55Research / Pharmaceutical sciences / Health / European Union / Committee for Medicinal Products for Human Use / Directive 2001/83/EC / Summary of Product Characteristics / Medicinal product / Biosimilar / Clinical research / Pharmaceuticals policy / Pharmacology

CMDh RECOMMENDATION ON IMPLEMENTATION OF ARTICLE 30 DECISIONS cf. DIRECTIVE[removed]EC, AS AMENDED FOR GENERIC/HYBRID/BIOSIMILAR MEDICINAL PRODUCTS APPROVED THROUGH MRP/DCP Doc. Ref.: CMDh[removed]Rev. 5, July 2013

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Source URL: www.hma.eu

Language: English - Date: 2013-08-01 10:03:34
56Health / Pharmacology / Macrolides / Tacrolimus / Astellas Pharma / European Medicines Agency / Immunosuppressive drug / Transplant rejection / Committee for Medicinal Products for Human Use / Medicine / Pharmaceutical industry / Immunosuppressants

achanA April 27, 2007 Astellas Receives an European Commission Approval for Advagraf

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Source URL: www.astellas.com

Language: English - Date: 2008-09-18 21:27:09
57Whole medical systems / Pseudoscience / Homeopathy / Clinical research / Pharmaceutical industry / Biologic / Cell culture / Committee for Medicinal Products for Human Use / Alternative medicine / Biology / Medicine / Health

Microsoft Word - PtC_Biological-for public consultation-HMPWG

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Source URL: www.hma.eu

Language: English - Date: 2014-12-24 05:41:23
58Computing / Pascal / Committee for Medicinal Products for Human Use / Programming language theory

Report from the CMDh meeting held on 16th, 17th and 18th July 2012 Impact of the implementation of the new pharmacovigilance legislation (Regulation (EU) No[removed]and Directive[removed]EU) on Marketing Authorisations

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Source URL: www.hma.eu

Language: English - Date: 2012-07-26 10:37:53
59Committee for Medicinal Products for Human Use

Report from the CMDh meeting held on 16th, 17th and 18th January 2012 Topiramate and risk of congenital malformations The CMDh has endorsed the PhVWP report on topiramate and the risk of congenital malformations and reco

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Source URL: www.hma.eu

Language: English - Date: 2012-01-27 11:54:38
    60Committee for Medicinal Products for Human Use

    Report from the CMDh meeting held on 14th, 15th and 16th January 2013 Implementation of the new pharmacovigilance legislation (Regulation (EU) No[removed]and Directive[removed]EU) The CMDh recommends marketing authoris

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    Source URL: www.hma.eu

    Language: English - Date: 2013-01-23 09:55:20
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