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
