News and Educations

HALMED joins the International Rare Disease Day Manifestation

18.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) will, in collaboration with the Croatian Association for Rare Diseases participate in the activities supporting the International Rare Disease Day.

In many Croatian towns, HALMED representatives will be holding workshops about the importance of adverse reaction reporting. They will also speak about the importance of adverse reaction reporting, the role of the Agency and medicines affordability after the EU Accession on the 3rd Croatian Symposium and National Conference on Rare Diseases with International Participation, organised by the Croatian Society for Rare Diseases, Croatian Medical Association and Croatian Association for Rare Diseases.

Detailed overview of workshops and information regarding the International Rare Diseases Day manifestation are accessible under the link below.

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Follow-up information on the expected shortage of human tetanus immunoglobulin-containing medicinal product

03.02.2014

Following to the Information on the expected shortage of medicinal products produced by Imunološki zavod d.d., published on the 23 October 2013 with the aim to ensure an adequate market supply with medicines, HALMED wants to highlight that there is no other human tetanus immunoglobulin-containing medicinal product authorised in Croatia, therefore the Croatian market may be supplied only with a medicinal product not authorised in Croatia. Due to the aforementioned, we invite wholesale license holders to act according to the legal
obligation to ensure prompt, permanent and adequate supply of the Croatian market and find the medicinal product of another manufacturer and submit an application to HALMED for import of the medicinal product not authorised in Croatia (“interventional import”).

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Questions and answers on combined oral contraceptives – information for patients

28.01.2014

A comprehensive review of the benefits and risks of oral contraceptives was recently carried out paying special attention to the risk of formation of blood clots associated with the use of these medicines.
Hereby, HALMED wants to provide more information on the risk of blood clots associated with use of combined oral contraceptives; including information on conditions increasing the risk of blood clots, information on signs and symptoms of blood clot and information when to tell the doctor or pharmacist about using these medicines.
Taking account that the recent benefit risk ratio referred to formation of blood clots, this document contains a number of information related to this risk.
The data concern only progestogen-containing medicines and not ethynylestradiol or estradiol.

The questions and answers list of combined hormone contraceptives is accessible here.

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Dear Healthcare Professional Letter on the risk of thromboembolism associated with use of combined hormone contraceptives (Adexa, Belara, Cilest, Estal, Evra, Lindynette, Logest, Novynette, NuvaRing, Qlaira, Yasmin, Yaz)

28.01.2014

Bayer d.o.o., Farmal d.d., MSD d.o.o., Sandoz d.o.o. and Johnson&Johnson SE d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA), have sent a letter to healthcare professionals on the results of safety assessment of combined hormone contraceptives (CHC) carried out in Europe and the newest evidence on the risk of thromboembolism associated with certain CHC.

Detailed information, the Dear Healthcare Professional Letter and information on CHC for patients in a Q&A form are accessible here.

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