viernes, 30 de agosto de 2013

WHO Pharmaceuticals Newsletter No. 4, 2013




Regulatory Matters


Almitrine-containing medicines ............................................................... 4


Codeine ........................................................................................... 4


Cyproterone and ethinylestradiol containing medicinal products ....................... 5


Diclofenac ................................................................................. 5


Hydroxyethyl starch intravenous infusion .................................................... 6


Ketoconazole ..................................................................................... 7


Olmesartan medoxomil .......................................................................... 7


Strontium ranelate ............................................................................... 7


Retigabine .......................................................................................... 8


Varenicline tartrate and bupropion hydrochloride ........................................... 8


Zolpidem containing products .................................................................... 9


Safety of medicines


Insulin glargine ..................................................................................... 10


Olanzapine Pamoate .............................................................................. 10


Renin-angiotensin-system (RAS)-acting agents ............................................... 10


Signal


Agomelatine and QT prolonged ............................................................... 12


Response from Servier .......................................................................... 18


Tapentadol and Aggressive reaction .......................................................... 19


Response from Grünenthal GmbH and Janssen Pharmaceuticals, inc. .................. 22


Feature


Tenth Meeting of the WHO Advisory Committee on Safety of Medicinal
Products (ACSoMP) ................................................................................ 24