18.02.2014
The Croatian Pharmaceutical Society (HFD) and the Agency for Medicinal Products and Medical Devices (HALMED) are organising the Course on the new Croatian Pharmacopoeia Edition, as a part of permanent education for pharmacists to be held on the 5 March 2014 in the HFD lecture hall (Masarykova 2) in Zagreb.
Detailed information is available under the link below.
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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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17.02.2014
The Conference ”26th Annual DIA EuroMeeting” will be held from 25 – 27 March 2014 in Vienna, organised by Drug Information Association (DIA).
Detailed information is available under the link below.
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17.02.2014
The list of newly approved medicinal products for the period between 1st January 2014 and 31st January 2014 is available in the continuation of this notice.
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11.02.2014
During its meeting in February 2014, the Pharmacovigilance and Risk Assessment Committee (PRAC) did not start any safety review of medicines, neither new recommendations were adopted and the Committee focused on the wide spectrum of its responsibilities encompassing all aspects of risk management regarding the use of medicines.
Detailed information is available under the following link.
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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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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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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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24.01.2014
The European Medicines Agency (EMA) has started a review of emergency contraceptives to assess whether increased body weight and body mass index reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or conceptive failure.
Detailed information is accessible under the link below.
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21.01.2014
The Agency for Medicinal Products and Medical devices (HALMED) has published the first Supplement of the online Croatian Pharmacopoeia 3.0 edition, labelled 3.1. This Supplement is based on the first Supplement of the eighth European Pharmacopoeia Edition published on 1 October 2013, entering into force on 1 April 2014.
Detailed information is available under the following link.
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