ZimultiTreatment for Obesity
Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti
International Nonproprietary Name (INN): rimonabant
LONDON, July 19, 2007-On 19 July 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal products Acomplia/Zimulti. The Marketing Authorisation Holder for these medicinal products is sanofi-aventis.
The CHMP adopted a new contraindication as follows:
"Ongoing major depressive illness and/or ongoing antidepressive treatment"
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full contraindications for Acomplia/Zimulti will be as follows****:
- "Hypersensitivity to the active substance or to any of the excipients.
- Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)"
* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.
** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.
**** The text in bold represents the new or the amended contraindication.
Posted: July 2007
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- Rimonabant - Regulatory Update in Europe - November 14, 2007
- Rimonabant Regulatory Update in the United States - June 29, 2007
- Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA - June 14, 2007
- FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors - June 13, 2007
- Rimonabant USA: Update - Mar 26, 2007 - March 26, 2007
- Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant - March 26, 2007
- Rimonabant USA: Update - Feb 12, 2007 - February 12, 2007
- Rimonabant Update in the United States - December 8, 2006
- Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation - February 17, 2006
- Rimonabant Accepted for Filing By the FDA - June 23, 2005