News and Educations

HALMED host of the Pharmacovigilance and Risk Assessment Committee informal meeting

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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Dear Healthcare Professional Letter on placing on the market of new medicinal products Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 IU film-coated tablets

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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Information about shortage of medicines with combination of active substances cilazapril and hydrochlorothiazide (Co-Cazaprol and Cilazil Plus)

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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Information about temporary distribution and use disruption of the batch 37/I of the Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content), Institute of Immunology, 10 doses, suspension for injection

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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Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection

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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Information on temporary recall of Cefexin 100 mg/5 ml powder for oral suspension (cefiximum)

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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