Information about the shortage of medicinal products Dacarbazine Pliva 100 mg lyophilisate for solution for injection or infusion and Dacarbazine 200 mg lyophilisate for solution for injection or infusion
23.10.2013
The marketing authorisation holder for medicinal products Dacarbazine Pliva 100 mg lyophilisate for solution for injection or infusion and Dacarbazine Pliva 200 mg lyophilisate for solution for injection and infusion, Pliva Hrvatska d.o.o., has informed the Agency for Medicinal Products and Medical Devices about the shortage of these medicines on the Croatian market. This shortage is due to manufacturing problems that are not associated with the quality, safety or efficacy of the product.
The normalisation of the market with these medicinal products is expected in January 2014 and the Agency will be promptly informed by the marketing authorisation holder about any new information.
There is no other authorised medicinal product with the same active substance on the Croatian market and requests for import/entry will be handled according to the legal exemption scheme for medicinal products without the Croatian marketing authorisation.
