Product name:

Amineptine

CAS number:

57574-09-1

Synonyms:

7-[(10,11-Dihydro-5H-dibenzo{a,d}cyclohepten-5-yl)amino]hepatanoic acid hydrochloride

Country

Effective Date

Description of action taken
Grounds for decision

Brunei Darussalam

June 1999

The Medical Health Services Headquarters in the Ministry of Health has withdrawn all tablets of amineptine (Survector) from the market with effect from 30 June 1999. (Reference: Official letter to Regulatory Agencies, Servier Singapore, February 1999.)

France

January 1999

The Medicines Agency has announced that the marketing authorization for the antidepressant, amineptine (SurvectorR: Servier) has been suspended and withdrawn in France. These actions have been taken after an evaluation of amineptine revealed a potential for abuse and risk of dependence. (Reference: Infofax Pharmacovigilance, Agence du Médicament, Saint-Denis, 22 January 1999.)

Italy

1999

Morocco

June 1999

The National Advisory Commission for Pharmacovigilance has decided to suspend the marketing authorization for amineptine. This action is based on international data concerning the potential abuse and risk of dependence associated with the intake of this product. (Reference: Letter from the Directorate of Medicines and Pharmacy, Rabat, 24 August 1999.)

Oman

April 2000

The Directorate General of Pharmaceutical Affairs & Drug Control has rescheduled amineptine as a non-psychotropic restricted controlled item because of international data concerning its potential abuse and risk of dependence. (Reference Circular No. 25/2000 Directorate General of Pharmaceutical Affairs, Ministry of Health, Sultanate of Oman 25/4/2000.)

Thailand

January 1999

The Ministry of Health has withdrawn preparations of amineptine following action taken in France. (Reference: E-mail communication from the Food and Drug Administration, Ministry of Health, Bangkok, Thailand, 28 January 1999).

United Arab Emirates

12 January 1999

The Ministry of Health has banned the sale of amineptine on account of a potential for abuse and risk of dependence. (Reference: Communication with WHO, 10 July 2000.)

Viet Nam

August 1999

The Drug Administration of Viet Nam in the Ministry of Health has withdrawn approval for the antidepressant, amineptine (Survector). This follows the decision taken by France to suspend amineptine on the basis of abuse and dependency potential. (Reference: Directive from Ministry of Health, Drug Administration of Viet Nam, No. 41/1999/QD-QLD, 5 August 1999.)