What's New?

  • Email
  • Help

September 2015

Filter by:
Date Content
04/09/2015CMDh scientific conclusions and grounds for variation, amendments to the product information and timeteble for the implementation: rabbit anti-human thymocyte PSUSA/00010184/201412
04/09/2015Demonstrating significant benefit of orphan medicines concepts, methodology, and impact on access, European Medicines Agency, London, UK, From: 07-Dec-2015, To: 07-Dec-2015
04/09/2015News and press releases: Demonstrating significant benefit of orphan medicines
04/09/2015How to apply for orphan designation (updated)
04/09/2015Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 20, Authorised
04/09/2015List of nationally authorised medicinal products: amiodarone PSUSA/00000166/201412
04/09/2015CMDh scientific conclusions and grounds for variation, amendments to the product information and timeteble for the implementation: amiodarone PSUSA/00000166/201412
04/09/2015New vacancy: Temporary Agent, Quality Specialist
04/09/2015New vacancy: Contract Agent, EU Institutional Liaison Support Officer
04/09/2015New vacancy: Temporary Agent, Risk Management Specialist
04/09/2015Careers (updated)
04/09/2015New vacancy: Temporary Agent, Business Analyst
04/09/2015Accelerated development of appropriate patient therapies: a sustainable, multi-stakeholder approach from research to treatment outcomes (ADAPT SMART project) kick-off meeting, European Medicines Agency, London, UK, From: 04-Sep-2015, To: 04-Sep-2015
03/09/2015Regulatory and procedural guideline: The dates of 2016 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel European Medicines Agency-health-technology-assessment requests (updated)
03/09/2015Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Dermatology (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): RoActemra,

Tocilizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Misoprostol

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Palovarotene

Therapeutic area: Other (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Peanut allergen extract

Therapeutic area: Pneumology-allergology (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Norovirus GI.1 virus-like particle antigen / norovirus GII.4 virus-like particle antigen

Therapeutic area: Vaccines (updated)
02/09/2015Opinion/decision on a Paediatric investigation plan (PIP): -,

Levomilnacipran

Therapeutic area: Neurology (updated)
02/09/2015Report: Annual activity report 2014
02/09/2015European medicines agency Standard operating procedure (SOP): Standard operating procedure for review and approval of VICH guidelines by CVMP and its working parties (updated)
02/09/2015European medicines agency Standard operating procedure (SOP): Standard operating procedure on the evaluation procedure for applications and requests for the establishment of maximum residue limits (MRLs) under Articles 3, 9, 10 or 15 of Regulation (EC) 470/2009 (updated)
02/09/2015Publications (updated)
02/09/2015Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 0, Authorised
01/09/2015Human medicines European public assessment report (EPAR): Omidria,

phenylephrine / ketorolac

Revision: 0, Authorised
01/09/2015Human medicines European public assessment report (EPAR): Unituxin,

dinutuximab

Revision: 0, Authorised
01/09/2015Notices of calls for tender - 2014 (updated)
01/09/2015Human medicines European public assessment report (EPAR): Kanuma,

sebelipase alfa

Revision: 0, Authorised
01/09/2015Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency: Questions and answers (updated)
01/09/2015News and press releases: EMA’s medical literature monitoring enters into full operation
01/09/2015New functionalities in support of the medical literature monitoring service - User manual: EV ICHISCR Export Manager, MLM EVWEB and tracking spreadsheets (updated)
01/09/2015European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting, European Medicines Agency, London, UK, From: 04-Jun-2015, To: 04-Jun-2015 (updated)
01/09/2015European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 04-Jun-2015, To: 04-Jun-2015 (updated)
01/09/2015Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 26, Authorised