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European Medicines Evaluation Agency (EMEA) Company Profile

20:58 EDT 19th July 2018 | BioPortfolio

European Medicines Evaluation Agency (EMEA)

Location

7 Westferry Circus
Canary Wharf
London
E14 4H
United Kingdom

Contact

Phone: +44 (0)20 74188400
Fax: +44 (0)20 74188416
Email: mail@emea.eudra.org


News Articles [3215 Associated News Articles listed on BioPortfolio]

BRIEF—EMA updates on evaluation of advanced therapy medicines

The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy…

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.    

Alexion Submits MAA For ALXN1210 To European Medicines Agency

WASHINGTON (dpa-AFX) - Alexion Pharmaceuticals, Inc. (ALXN) announced Thursday the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ALXN1210, it...

First two CAR-T cell medicines recommended for approval in the European Union

The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel...

News and press releases: European Medicines Agency welcomes new Head of Veterinary Medicines

Ivo Claassen joins the Agency as of 1 March

CHART/TABLE: New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.    

Alexion Submits MAA For ALXN1210 To European Medicines Agency - Quick Facts

Alexion Pharmaceuticals, Inc. (ALXN) announced Thursday the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ALXN1210, its investigational long-acti...

European Medicines Agency Validates Type II Variation for Merck's KEYTRUDA (pembrolizumab) in Combination with Pemetrexed (ALIMTA) and Platinum Chemotherapy as First-Line Therapy in Metastatic Nonsquamous NSCLC, Based on Phase 3 KEYNOTE-189 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for...

Drugs and Medications [186 Associated Drugs and Medications listed on BioPortfolio]

Terbinafine hydrochloride [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use terbinafine hydrochloride safely and effectively. See full prescribing information for terbinafine hydrochloride tablets.Terbinafine H...

Cimetidine [Walgreen Company]

Walgreen Co. Cimetidine 200 Drug Facts

Dg health heartburn relief [Dolgencorp, LLC]

Dolgencorp, LLC Heartburn Relief Drug Facts

Acid reducer [Rite Aid Corporation]

Rite Aid Corporation Acid Reducer Drug Facts

Smart sense acid reducer [Kmart Corporation]

Kmart Corporation Acid Reducer Drug Facts

PubMed Articles [2921 Associated PubMed Articles listed on BioPortfolio]

Re: Availability of Evidence of Benefits on Overall Survival and Quality of Life of Cancer Drugs Approved by European Medicines Agency: Retrospective Cohort Study of Drug Approvals 2009-2013.

Effect of European Medicines Agency's regulatory measures on nimesulide utilization in Portugal.

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-marke...

Quantitative evaluation of the matrix effect in bioanalytical methods based on LC-MS: A comparison of two approaches.

Liquid chromatography coupled to mass spectrometry (LC-MS) is a powerful tool for studying pharmacokinetics and toxicokinetics. Reliable bioanalysis requires the characterization of the matrix effect,...

Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes.

Small and medium-sized enterprises (SMEs) are an important source of innovative medicines. Compared with their larger counterparts, they experience challenges as a result of insufficient human and fin...

Clinical Trials [2222 Associated Clinical Trials listed on BioPortfolio]

Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom

The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid g...

PENTA Fosamprenavir Study

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above...

A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice

This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety U...

Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Ag...

Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children...

Companies [1867 Associated Companies listed on BioPortfolio]

European Medicines Agency

European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London.ts main responsibility is the protection and promotion of public and animal health, through t...

European Medicines Evaluation Agency (EMEA)

European Medicines Evaluation Agency (EMEA)

European Generic medicines Association

The EGA is the official representative body of the European generic pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimu...

European Directorate for the Quality of Medicines

The EDQM was created in 1996 and is a Directorate of the Council of Europe. Its premises have been especially designed for its various activities. Today the EDQM is organised into nine administrative...

Australia New ZealandTherapeutic ProductsAuthority

The trans Tasman therapeutic products agency project has involved New Zealand and Australia giving consideration to establishing a joint agency to regulate therapeutic products (medicines, medical dev...

More Information about "European Medicines Evaluation Agency (EMEA)" on BioPortfolio

We have published hundreds of European Medicines Evaluation Agency (EMEA) news stories on BioPortfolio along with dozens of European Medicines Evaluation Agency (EMEA) Clinical Trials and PubMed Articles about European Medicines Evaluation Agency (EMEA) for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of European Medicines Evaluation Agency (EMEA) Companies in our database. You can also find out about relevant European Medicines Evaluation Agency (EMEA) Drugs and Medications on this site too.

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