Anvisa seizes irregular batches of multiple sclerosis drug Ocrevus

Brazil’s National Health Surveillance Agency (Anvisa) has ordered the seizure of two irregular batches of the medication Ocrevus (ocrelizumab) 300 mg/10 ml. The affected batches are identified as H7953B14 and H7953B06.

Ocrevus is used to treat recurrent forms of multiple sclerosis and primary progressive multiple sclerosis. While the medication itself was manufactured regularly by the registered holder, Anvisa stated these specific batches were intended for other countries and entered Brazil irregularly. Consequently, the agency cannot guarantee that necessary sanitary conditions were maintained to ensure the integrity of the medicine during distribution.

The batches were distributed in July by Laf Med Distribuidora de Medicamentos e Materiais Hospitalares Ltda, a company that Anvisa reports is not authorized to operate in the pharmaceutical market, as its operating authorization has been inactive. The agency has prohibited the storage, sale, distribution, export, import, advertising, and transport of these specific batches. Laf Med has previously been cited for distributing counterfeit medications.