Product name:

Ebrotidine

CAS number:

100981-43-9

Synonyms:

p-bromo-N-[(E)-({2-[{(2-[diaminomethylene)amino]-4- thiazoyl}methyl)thio]ethyl}amino)methylene]benzenesulfonamide

Country

Effective Date

Description of action taken
Grounds for decision

Peru

October1998

La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of Health withdrew marketing authorization for the histamine H₂ receptor antagonist ebrotidine (Ebrocit) because of reports of serious liver dysfunction particularly on long-term treatment and when the drug was administered with anti-inflammatory agents and corticosteroids. (Reference: Alerta DIGEMID No. 07-98, 12 October 1998).