Distribution, Manufacturing and Inspection

Notice on reintroducing the batch of Glucose 10% Viaflo solution for infusion on the market

17.12.2014

Following to the Notice on temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate) of the marketing authorisation holder, Agmar d.o.o., published on 31 October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the reintroducing of the batch 14C17E3M of this medicine on the Croatian market.

More information is accessible under the link below.

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Notice on quality defect of the batch H55110 of Prevenar 13

08.12.2014

Pfizer Croatia d.o.o., the representative of the marketing authorisation holder in the Republic of Croatia for Prevenar 13 has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batch H55110 of this medicinal product. It is discovered that the package leaflet for Prevenar 13 in single dose vial (0.5 ml) is inserted in the packaging for Prevenar 13 in single dose pre-filled syringe (0.5 ml). These two package leaflets differ in the title and in the section “How Prevenar 13 appears and package content”. Both vaccines are already ready for use, but when administering the vaccine in single dose vial, the solution should be aspirated into the syringe.
HALMED agrees that the marketing authorisation holder’s representative distributes these batches with accompanying notes intended to wholesalers, healthcare professionals and patients as well as the correct package leaflet.

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Notice on the temporary discontinuation of distribution and use of the batch B514ADof Medoclav 1000 mg + 200mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

27.11.2014

Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation of distribution and use of the batch B514AD of this medicine from the Croatian market. The discontinuation procedure of distribution and use of this batch is carried out based on the quality defect reported from a healthcare professional about a different colour in two bottles from the same package.

The marketing authorisation holder has notified HALMED about other batches on the market that are available for treatment, so that the supply of the Croatian market will not be at risk.

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Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion

14.11.2014

Fresenius Kabi d.o.o., the marketing authorisation holder for medicinal product Ciprofloxacin Kabi 400 mg/200 ml solution for infusion has upon request of the Agency for Medicinal Products and Medical devices (HALMED) initiated a procedure of temporary supply and use discontinuation of the batch 15HG229F1 of this medicinal product from the Croatian market.
The procedure of temporary supply and use discontinuation of this batch has been initiated due to a suspected quality defect.

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Notice on potential risk of cracks in vials of Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

27.10.2014

GlaxoSmithKline, the marketing authorisation for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the potential incident of cracks of these medicine.

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