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Information for citizens
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««« IMPORTANT! »»»
Information for medical specialists

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia and has updated recommendations to manage this risk issued at the beginning of the review.

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PRAC concludes review of Zydelig and issues updated recommendations for use

 
Information for medical specialists

EMA to review modified-release paracetamol

Measures to minimise risk and reduce harm of overdose to be considered

More information on this is included in the hyperlink below:

Paracetamol-modified release

 
Pharmacovigilance / «Companies»

Single, central platform now mandatory for all periodic safety update reports

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

As of 13 June 2016, all periodic safety update reports (PSURs) for human medicines authorised in the European Union (EU) must be submitted to the PSUR repository, which has been developed by the European Medicines Agency (EMA) in close collaboration with EU Member States and the industry.

More information on this is included in the hyperlink below:

Single, central platform now mandatory for all periodic safety update reports (10/06/2016)

 
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