22.05.2014
Farmal d.d., the marketing authorisation holder for lisinopril Farmal 10 mg tablets (lisinopril) has informed the Agency for Medicinal Products and Medical Devices (HALMED) on recall of one batch of this medicine from the Croatian market. The batch 130501, shelf life : 05, 2016 is being recalled due to quality defects.
Further information is accesible under the link below.
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22.05.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is host of an informal meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC), opened today in Dubrovnik. The meeting of the central EMA’s committee for review and safety monitoring of medicines for human use in the European Union is taking place from 22 -23 May 2014 and organised under the Greek Presidency of the EU.
Detailed information is accesible under the link below.
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22.05.2014
Belupo, medicines & cosmetics d.d. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals of placing on the market of new medicines: Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 film-coated tablets. This medicines will replace Silapen 1 000 000 IU tablets and Silapen 1 500 000 IU tablets, and therefore it might be possible for some time that all of these medicines will be on the market.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.
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19.05.2014
Krka-farma d.o.o., the marketing authorisation holder for Co-Cazaprol 5 mg/12.5 mg film-coated tablets and Pliva Hrvatska d.o.o., the marketinga authorisation holder for Lilazil Plus 5 mg + 12.5 mg film coated tablets, have notified the Agency for Medicinal Products and Medical devices (HALMED) on shortage of these medicinal products on the Croatian market.
The normalisation of the Croatian market with Co-Cazaprol is expected by the end of June 2014, and normalisation of the market with Cilazil Plus is expected by the end of July 2014.
Detailed information is accessible under the link below.
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16.05.2014
Institute of Immunology, the marketing authorisation holder for the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection, has at request of the Agency for Medicinal Products and Medical Devices (HALMED) temporary interrupted the distribution and use of the batch 37/1 of this vaccine on the Croatian market. There are sufficient quantities of the other on the Croatian market which is not affected by this suspected quality defect and that may be further distributed and used so that the vaccination program is not at risk.
Detailed information is accessible under the link below.
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16.05.2014
The list of newly approved medicinal products for the period between 1st April 2014 and 30th April 2014 is available in the continuation of this notice.
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13.05.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is inviting tenders for selling of a basic asset:
- Housing container, Inventary No 001923/800272
More information is accessible under the link below.
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09.05.2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May meeting.
Detailed information is accessible under the link below.
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09.05.2014
Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Esmeron 10 mg/ml solution for injection has started, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure for temporary interruption of the batch 557867 of this medicine from the Croatian market.
The procedure of temporary interruption of distribution and use of this batch of the medicine has been initiated due to a suspected quality defect, after HALMED received on 8 and 9 May 2014 from healthcare professionals six reports to allergic reactions, ranged from mild redness and rash to anaphylactic reaction.
More information is accessible under the link below.
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30.04.2014
Pliva Croatia d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is available under the link below.
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