WHO Pharmaceuticals Newsletter 1997, No. 11&12
(1997; 24 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAcetylsalicylic acid and paracetamol - prescription control: United Kingdom
View the documentChlormezanone - marketing authorization withdrawn: Germany
View the documentCounterfeit antimalarial detected: Kenya
View the documentDiphenhydramine - warning statements: United States of America
View the documentGeriatric use - added to labelling: United States of America
View the documentHerbal “Fen-Phen” - warning concerning “natural” anti-obesity alternatives: United States of America
View the documentHIV protease inhibitors - hyperglycaemia: United Kingdom
View the documentIrinotecan - revised data sheet: warning & precautions for use: Japan
View the documentLamotrigine - warning: severe cutaneous reactions: Australia
View the documentLaxatives containing phenolphthalein - recommendation to revoke marketing authorization: Germany
View the documentLevothyroxine sodium - new drug applications to be submitted: United States of America
View the documentLysine amidotrizoate in ionic contrast media - withdrawn: Germany
View the documentMelatonin - prescription control: New Zealand
View the documentMetamizole sodium - prohibited: Nepal
View the documentNSAIDs, including acetylsalicylic acid - proposed risk-based framework: New Zealand
View the documentPaediatric data - labelling to be required for new drugs: United States of America
View the documentParacetamol - restrictive measures: Ireland
View the documentPemoline - withdrawn: hepatotoxicity: United Kingdom
View the documentSodium hydrogen bicarbonate (paediatric) - prohibited: Nepal
View the documentSuxamethonium chloride - warnings: cardiac arrest and hyperkalaemia: United States of America
View the documentTerfenadine - restrictive measures: Ireland
View the documentTerfenadine and terfenadine/pseudoephedrine - warnings concerning interactions: United States of America
View the documentTramadol - not recommended as first choice for moderate pain: Norway
View the documentTramadol - rescheduled: Oman
View the documentTrihexyphenidyl - rescheduled: Oman
View the documentVigabatrin - visual field defects: Australia
View the documentWomen in clinical trials - proposed rule: United States of America
View the documentZafirlukast - possible association with Churg-Strauss syndrome: United States of America
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine
 

Chlormezanone - marketing authorization withdrawn: Germany

Germany. Following the worldwide withdrawal of products containing the muscle relaxant chlormezanone (TrancopalR) by the manufacturer Sanofi Winthrop and subsequent similar action by generic manufacturers, the Federal Institute of Drugs and Medical Devices has now withdrawn the marketing authorization for all medicinal products containing chlormezanone. These action were taken after a risk of severe cutaneous reactions and hepatotoxicity was identified in association with the use of chlormezanone. No products now remain on the market.

[See also Pharmaceuticals Newsletter Nos. 1&2, January & February 1997 and Alert No. 53 dated 18 October 1996]

Reference: Pharmazeutische Zeitung Vol. 142(44): 3908 (1997).

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Last updated: May 3, 2013