Distribution, Manufacturing and Inspection

Information about the interruption in manufacturing and supply chain with Sodium Hydrogen Carbonate Pliva 84 mg/ml solution for infusion

03.03.2014

The marketing authorisation holder for Sodium Hydrogen Carbonate Pliva 84 mg/ml solution for infusion, Pliva Hrvatska d.o.o., has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the interruption in manufacturing and supply chain of the Croatian market with this medicine and revocation of the marketing authorisation.

The decision on interruption in manufacturing and supply chain with this medicine has been taken due to commercial reasons and it is not linked to quality, safety or efficacy of the medicinal product.

There is no other authorised medicine with the same active substance and HALMED will approve entry/import at request of medicines not authorised in the Republic of Croatia, but in the other EU Member States.

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