Advice
The marketing authorisation for rosiglitazone maleate/metformin hydrochloride (Avandamet) has been withdrawn.
The SMC Advice has been removed from the website.
On 23 September, 2010, the European Medicines Agency’s (EMA) Committee on Medicinal Products for Human Use (CHMP) recommended the suspension of the marketing authorisation for Avandia, Avandamet and Avaglim (rosiglitazone) as the benefits no longer outweigh the risks.
www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500096996.pdf
"Medicine details
- Medicine name:
- Rosiglitazone maleate/metformin hydrochloride (Avandamet®)
- SMC ID:
- 140/04
- Indication:
- Type 2 diabetes mellitus
- Pharmaceutical company
- GlaxoSmithKline UK Ltd
- BNF chapter
- Endocrine system
- Submission type
- Abbreviated
- Status
- Withdrawn
- Date advice published
- 13 December 2004