The European Medicines Agency (EMA) approves Cardiome ... of pulmonary arterial hypertension (PAH) under its Centralized Authorization Procedure. The streamlined process, covering all 28 EU ...

The answers that comprise the “EMA Procedural Advice for Users of the Centralised Procedure for Similar Biological Medicinal Products Applications” were all already in public domain ...

Protalix stated that the centralized procedure via the EMA allows for the submission of a single marketing authorization application to the European Union, and, if approved, allows Chiesi ...

For cases where the vaccine under development is composed of a whole-inactivated virus or live attenuated virus, HMA and EMA are also recommending that marketing authorization holders follow the ...

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between ...

aeruginosa) infection. “We are pleased that the EMA has agreed to review Pulmaquin through the centralized review process,” said Dr. Juergen Froehlich, Aradigm’s Chief Medical Officer.

The European Medicines Agency (EMA) statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009. However, ...