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.

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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 temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate)

30.10.2014

Agmar d.o.o., the marketing authorisation holder for Glucose 10% Viaflo solution for infusion (glucose hydrate), is carrying out, at the Agency’s request , the recall procedure of the batch 14C17E3M of this medicine.

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Recall of two batches of Ibustar for children 20 mg/ml oral suspension (ibuprofen)

24.10.2014

Berlin-Chemie Menarini Croatia d.o.o., the marketing authorisation holder for Ibustar for children 20 mg/ml oral suspension (ibuprofen), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batches 32004 and 41005 of this medicinal product due to a discovered quality defect.

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Notice on continuation of delivery of two Enbrel 25 mg powder and solvent for solution for injection batches

22.10.2014

Following to the Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection, released on 8th October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the continuation of delivery of batches H58480 and H76658 of this medicine.

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Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection

08.10.2014

Pfizer Croatia d.o.o., the marketing authorisation’s holder representative in the Republic of Croatia for Enbrel 25 mg powder and solvent for solution for injection, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batches H58480 and H76658 of this medicine.

Detailed information is accessible under the link below.

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Recall of the batch AIIM/1P of Torisel with corresponding solvent batch AHZW/99

07.10.2014

Pfizer Croatia d.o.o., the Croatian representative of the marketing authorisation holder for Torisel has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch AIIM/1P of this medicine with corresponding solvent batch AHZW/pp from the market due to a quality defect.

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Cefexin 100 mg/5 ml powder for oral suspension (cefixime) reintroduced into the market

06.10.2014

Following to the Information on temporary recall of Cefexin 100 mg/5 ml powder for oral suspension (cefiximum), released on 30 April 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about the reintroducing of this medicinal product with a modified syringe.
Detailed information is accessible under the link below.

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Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefixime) reintroduced into the market

06.10.2014

Following to the Information on temporary recall of Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefiximum) released on 30 April 2014. the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about the reintroducing of this medicinal product with the modified syringe.
Detailed information is accessible under the link below.

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