European Medicines Agency (EMA)
Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation
... the European Medicines Agency (EMA) concluded a review [13] on the safety and efficacy of valproate and related substances in female children, women of childbearing po- tential and pregnant ...
6
European Medicines Agency. Annual report 2010
... the Agency to support the scientifically sound development of advanced-therapy medicinal products (ATMPs), including gene-therapy, somatic-cell- therapy or human-tissue-engineered products, and other emerging ...
83
European Medicines Agency. Annexes of the annual report 2011
... of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the European Medicines ...The Agency receives safety reports ...
117
European Medicines Agency. Annexes of the annual report 2010
... paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical ...
107
European Medicines Agency. Annual report of the European Medicines Agency 2008
... It is my pleasure to write a short message as a foreword to the Annual Report of the European Medicines Agency for 2008. The report provides an extensive overview of the substantial activities of the ...
158
European Medicines Agency. Annual report 2009
... • A joint scientific opinion on antimicrobial resistance, focusing on infections transmitted to humans from animals and food (zoonoses), was prepared and published by ECDC, EFSA, the European Medicines ...
81
European Medicines Agency. Annual report highlights 2010
... the European Medicines Agency is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines to agree on a ...
16
European Medicines Agency. Annual Report 2009. Annexes
... of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the European Medicines ...The Agency receives safety reports ...
101
REGULATORY REQUIREMENTS OF DRUG MASTER FILES BY FOOD AND DRUG ADMINISTRATION (USA), EUROPEAN MEDICINES AGENCY (EUROPE) AND HEALTH CANADA (CANADA) AND THEIR COMPARISON
... an agency of the government that is responsible for protecting public health in safety ...(USA), European Medicines Agency (Europe) and Health Canada (Canada) and their ...
5
European Medicines Agency. Annual report highlights 2009
... the Agency, followed by an official from the Japanese authorities in November ...The European Medicines Agency appointed a staff member as a liaison officer to the FDA in July ...The ...
7
European Medicines Agency. Annual report 2011. Overview of the Agency's contribution to science, medicines and health in the European Union
... the Agency published a full list of the networks that applied for Enpr-EMA membership in January 2011, indicating those that met all of the criteria and those that needed to provide further clarification or did ...
64
European Medicines Agency. Annual report 2012: Annexes
... Annex 7 – Members of the Paediatric Committee Chair: Daniel BRASSEUR EMA contact: Paolo TOMASI Members • Fernando de ANDRÉS TRELLES Spain Alternate: Maria Jesús FERNÁNDES CORTIZO • Dina [r] ...
132
European Medicines Agency. The European Medicines Agency in 2006. Summary of the twelfth annual report of the EMEA
... The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products. Both procedures are based upon the principle of recognition of national authorisations. They ...
37
European Medicines Agency. The European Medicines Agency in 2007. Summary of the thirteenth annual report of the EMEA
... Review of piroxicam-containing medicines, triggered by safety concerns over gastrointestinal side effects and serious skin reactions. The CHMP concluded that piroxicam should no longer be used for treatment of ...
32
European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008
... ‘Orphan’ medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10,000 persons in the European ...such ...
17
A PROCESSION AT THE EU REGULATORY GUIDELINESJ. Balasubramanian*, T. Muthukumaran, S. Hariram, G. A. Nandhini, K. SaisugathriDOWNLOAD/VIEW
... Under the new EU drug approval process, pharmaceutical companies may use either a centralized or a decentralized procedure to obtain approval to market their pharmaceutical products in more than one Member State using ...
13
European Medicines Agency. Annual report of the European Medicines Agency 2006
... If food-producing animals are treated with medicines, residues may remain in the food produced by or from them. To obtain a marketing authorisation for a veterinary medicinal product intended for use in a ...
134
European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005
... the Agency launched the ‘SME Office’, dedicated to addressing the particular needs of smaller companies, following the entry into force of the new SME Regulation 3 to implement provisions relating to incentives ...
23
Roflumilast: first phosphodiesterase 4 inhibitor approved for treatment of COPD
... the European Medicines Agency Committee for Medicinal Products for Human Use adopted an opposite stance to PADAC and recommended the granting of a marketing authorization for ...the European ...
12
European Medicines Agency. Annual report of the European Medicines Agency 2005
... In 2005, the CVMP also reconsidered its previous opinion on the referral procedure for Micotil 300 (tilmicosin), initiated in 2004 to investigate concerns regarding user safety following an accidental human fatality ...
112