Pharmacovigilance

Recall of the one batch of Neurobion 100 mg + 100 mg + 1 mg solution for injection

22.07.2014

Merck d.o.o., the marketing authorisation holder for Neurobion 100 mg + 100 mg + 1 mg solution for injection has in collaboration with the Agency for Medicinal Products and Medical Devices initiated a recall of the batch 180707 of this medicine.

The recall is due to an error on the inner and outer labelling of the medicine, where there is "subcutaneous use” instead of "intramuscular use”. The package leaflet is correctly labelled with "intramuscular use”.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.

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