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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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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22.09.2014
The German competent authority for medicines has notified HALMED that certain amount of erythropoietin-containing medicinal products has disappeared from stocks of an authorised wholesaler. Taking account that disappeared medicines have been outside the legal cold chain, or controlled storage conditions, they will be considered as counterfeit, should they be placed again on the market.
Detailed information is accessible under the link below.
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30.07.2014
Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Norcuron 10 mg powder for solution for injection or infusion, has informed the Agency for Medicinal Products and Medicla Devices (HALMED) on the recall of the batches 665196 and 668521 of this medicine from wholesalers.
The recall is due to an error discovered in the Package leaflet.
Detailed information is accessible under the link below.
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29.07.2014
The Agency for Medicinal Products and Medical Devices (HALMED)has received via rapid alert system from the German competent authorities a notice about a number of suspected counterfeited products.
Neither of these suspected batches have been on the Croatian market.
Detailed information is accessible under the link below.
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28.07.2014
PharmaS d.o.o., the marketing authorisation for KlavoPhar 875 mg/125 mg film-coated tablets (amoxicillin, clavulanic acid), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the quality defect of this medicine.
The quality defect report refers to the outer and inner labelling of the product where the “Expiry date” and “Batch No” of certain batches are labelled in English instead of the Croatian language on the blister and package. The following batches have been affected by this quality defect: KTABV0001, KTABV0002, KTABV0003, KTABV0004, KTABV0005, KTABV0006, KTABV0007, KTABV0008, KTABV0009.
Detailed information is accessible under the link below.
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24.07.2014
Medical intertrade d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall from the market of all batches of Ecalin cream, Ecalin pessaries and Ecalin cutaneous spray, solution. These medicines are being recalled due to regulatory reasons, which means due to the expiration of the marketing authorisation granted by HALMED and under provisions laid down in the paragraph 2 of the Art. 113 of the Medicinal Products Act (Official Gazette, No 76/13) according to which a batch may remain in the distribution no longer than 18 months after the expiration of the marketing authorisation or shelf life.
Pharmacies are being advised to return the remaining stock to providing wholesalers.
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23.07.2014
Following to the Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection, published on 9 May 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is hereby informing about the returning of this batch to the market.
Detailed information is accessible under the link below.
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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”.
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18.07.2014
Pfizer Croatia d.o.o., the marketing authorisation holder for Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan) has upon Agency’s request initiated a temporary procedure of interruption and use of the batch HC 68E of this medicine. The procedure is due to a suspected quality defect report on the discovered turbid solution that HALMED received on 16 July 2014 by a healthcare professional.The interruption of use of this medicine will be in effect until the results of the extraordinary quality control have been achieved and conclusions on the discovered quality defect made, which will be promptly made publicly available.
The temporary interruption of dispensation and use relates only to the batch HC 68 of this medicine, whereas other available batches may be further dispensed and used.
Detailed information is available under the link below.
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