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- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > regulatory matters
- Keywords > safety
- Keywords > safety - vaccine
- Keywords > side effect
- Keywords > withdrawn products
- Keywords > effet indésirable
(2011; 23 pages)
In this edition of the WHO Pharmaceuticals Newsletter our readers will find reference to decisions around the world on some old medicines such as dextropropoxyphene, acetaminophene, bisphosphonates and quinine, as well as newer ones such as dolasetron, dronedarone, saquinavir and sitaxentan. Sitaxentan has been withdrawn worldwide by the manufacturer because of unpredictable serious liver injury. Read the background information from Australia, Canada and EMA.
In a feature article of this edition of the Newsletter we continue to give information about WHO’s Prequalification of Medicines Programme; this time about inspection of manufacturing sites for Active Pharmaceutical Ingredients (APIs).
A report of the latest meeting (8 – 9 December 2010) of the WHO Global Committee of Vaccine Safety is found as the second feature article of the Newsletter.