PUBBLICATO IL RAPPORTO MENSILE DEL PHARMACOVIGILANCE WORKING PARTY



EMEA, PHARMACOVIGILANCE WORKING PARTY (PHVWP) MONTHLY REPORT
Fonte: EMA. Giugno 2011



E' disponibile il rapporto mensile del Pharmacovigilance Working Party pubblicato sul sito web dell'EMA.
Tale rapporto riassume gli argomenti discussi nella riunione plenaria del PhVWP del 20-22 giugno 2011.

Sono riportate le seguenti tematiche:

DISCUSSIONS ON SAFETY CONCERNS
• Beta-blockers for ophthalmic use – Risk of systemic adverse reactions
• GEMCITABINE ACTAVIS – Risk of adverse reactions due to increased alcohol concentration after reconstitution error
• Hydrochlorothiazide – Use during breast-feeding
• Testosterone 10% for topical use – Risk of virilisation in children after exposure through interpersonal skin contact
GUIDELINES AND GENERAL MATTERS
• Meetings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in June 2011
• Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines
• Study of influential stakeholders’ expectations and attitudes regarding benefit-risk communication by the European Medicines Agency
• Driving under the Influence of Drugs, Alcohol and Medicines - The Integrated Project DRUID under the European Commission’s 6th Framework Programme