New Drug Applications

Zimulti

rimonabant

Treatment for Weight Loss

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.
Lactation.
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.

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FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors - June 13, 2007

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Rimonabant Accepted for Filing By the FDA - June 23, 2005