News and Educations

HALMED participates in the 5th public educational campaign for the promotion of rational use of antimicrobial medicines - JEKA

01.02.2013

The Agency for Medicinal Products and Medical Devices (HALMED) participates as a sponsor and participant of the 5th Public Educational Campaign on Promotion of Rational Use of Antimicrobial Medicines – JEKA. The main goal of this campaign is to reduce by means of a public campaign, the unnecessary and inappropriate use of antibiotics.
Further information about antibiotics and the JEKA action you may find in the continuation of this information.

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Dear Health Care Professional Letter about comparative data on the lesser effectiveness regimen based on the medicinal product Tyverb (lapatinib) as compared on Herceptin (trastuzumab) based regimen

01.02.2013

The company GlaxoSmithKline d.o.o., the marketing authorisation holder for the medicinal product Tyverb 250 mg film-coated tablets (lapatinib), has, in collaboration with the Agency for Medicinal Product and Medical Devices (HALMED) sent out a letter to health care professionals about the comparative data based on the medicinal product Tyverb 250 mg film-coated tablets as compared to the regimen based on the medicinal product Herceptin 250 mg powder for solution for injection (trastuzumab) in certain patient groups.

You may view the text of the letter in the continuation of this information.

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New instructions for preparation of a medicinal product utilisation report

31.01.2013

In order to improve and modernise the data gathering system, the Agency for Medicinal Products and Medical Devices (HALMED) is from 2013 introducing changes in the process of reporting the medicinal product utilisation which will enable the utilisation reporting for the previous year by means of a web application only.
Further information on the changes in submission procedure of medicinal products consumption are available in the Medicines/Drug utilisation/Instructions for preparation of a medicinal product utilisation report, or in the continuation of this information.

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European Medicines Agency has started the review of third- and fourth-generation combined oral contraceptives

30.01.2013

Due to a recent initiative to reduce the use of third- and fourth-generation combined oral contraceptives, the European Medicines Agency has been requested by France to review the benefits risks ratio of third- and fourth-generation (so called "newer" combined oral contraceptives) combined oral contraceptives. The review of benefits risks ratio is being carried out in order to determine whether there is a need to restrict the use of these medicinal products to women who cannot take other combined oral contraceptives. The EMA’s Pharmacovigilance Assessment Committee (PRAC) will be reviewing whether the currently available product information on combined oral contraceptives provides the best information possible for patients and doctors to take appropriate healthcare decisions. New information about the review by the PRAC will be available by the end of next week.
You may find further details in the continuation of this information.

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Questionnaire about the revision of the Croatian Pharmacopoeia

28.01.2013

In other to obtain necessary data for recognition of customer needs when preparing a new edition of the Croatian Pharmacopoeia, the Agency for Medicinal Products and Medical Devices has published a questionnaire about the revision of the Croatian Pharmacopoeia. The questionnaire is anonymous and intended to all users of the Croatian Pharmacopoeia.
The questionnaire and further information are available in the continuation of this information.

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Dear Health Care Professional letter about the reports of Severe Cutaneous Adverse Reactions associated with the use of the medicinal product Incivo 375 mg, film-coated tablets (telaprevir)

28.01.2013

The company Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for the medicinal product Incivo 375 mg, film-coated tablets (telaprevir) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of Severe Cutaneous Adverse Reactions (SCAR), associated with the use of the medicinal product Incivo. The letter reminds health care professionals on the current recommendations for the monitoring and treatment of skin adverse reactions listed in the Summary of Product Characteristics for Incivo 375 mg, film-coated tablets.

You may view the letter in the continuation of this information.

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Dear Health Care Professional letter about the risk of dose-related hepatotoxicity associated with Valdoxan 25 mg film-coated tablets (apomelatin)

24.01.2013

The company Servier Pharma d.o.o., the marketing authorisation holder for Valdoxan 25 mg film-coated tablets (apomelatin) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about several reports of serious liver injury associated with the use of the aforementioned medicinal product. The letter reminds health care professionals on the importance of monitoring of liver function tests in patients throughout their entire treatment.
You may view the letter to health care professionals in the continuation of this information.

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Information about the labelling of the medicinal product Sojourn para inhalata, liquid

23.01.2013

Markomed d.o.o., the marketing authorisation holder for the medicinal product Sojourn para inhalata, liquid, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) informed physicians about the labelling of the product.
In the second half of 2011, the Ministry of Health gave its consent for the import and placing on the market of the product in the original packaging. Therefore, this product exists in the original packaging in English on the Croatian market. The summary of product characteristics and the package leaflet in Croatian that are attached to the packaging are authorised by HALMED.
The company Minrad International, Inc. is declared on the original packaging as the manufacturer of the product, whereas the company Piramal Healthcare UK limited is declared as the manufacturer in the summary of product characteristics and patient information leaflet, which is in accordance with the dossier submitted in support of the application to HALMED. According to the aforementioned, the labelling of the medicinal product Sojourn para inhalata, liquid that is placed on the Croatian market is in compliance with the consent of the Ministry of Health about the exemption from the labelling in Croatian and the dossier approved by HALMED in the authorisation procedure.

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