News and Educations

HALMED introduced 1.1 million € worth EU IPA 2009 project “Preparation for eCTD and implementation of digital archive information system

19.09.2014

The Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED) , together with the project partners AAM Consulting and Ericsson Nikola Tesla, introduced on Tuesday, 16 September 2014 the results of the project “Preparation for eCTD and implementation of digital archive information system”. The ceremonial presentation took place at the Ericsson Nikola Tesla Company’s premises in Zagreb. This project that approaches HALMED towards the ideal “Paperless office”, is 1.120 000 € worth and is financed by the European Commission through the IPA 2009 programme.

More information is accessible under the link below.

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Dear Healthcare Professional Letter on the new/modified storage conditions of Octanate 1000 IU powder and solvent for solution for injection and Octanate 500 IU powder and solvent for solution for injection

16.09.2014

Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.
Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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HALMED applied for PIC/S membership

15.09.2014

The Agency for Medicinal Products and Medical Devices (HALMED) received on 5 September 2014 from the PIC/S Secretariat a confirmation that HALMED’s application for membership in the Pharmaceutical Inspection and Co-operation Scheme (PIC/S) is valid.

Pharmaceutical Inspection Co-operation Scheme (PIC/S) ensures an active co-operation in the field of good manufacturing practice, facilitates experience and information exchange, promotes improvement and harmonisation of standards and inspection procedures of pharmaceutical manufacturers and maintains mutual trust among competent authorities. The competent authority’s PIC/S membership is also beneficial to manufacturers as it reduces double inspections and opens access to some international markets.

Detailed information is accessible under the link below.

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Dear Healthcare Professional Letter on new risk minimisation measures for osteonecrosis of the jaw and hypocalcaemia in patients treated with denosumab 60 mg (Prolia)

11.09.2014

Amgen Europe B.V. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals on the new risk minimisation measures for osteonecrosis of the jaw (ONJ) and hypocalcaemia in patients treated with Prolia.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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Notice on cessation of production of Vagifem 25 microgram vaginal tablets (estradiol) and kliogest 2 mg/1 mg film-coated tablets (estradiol, norethisterone) for the Croatian market.

11.09.2014

Novo Nordisk Croatia d.o.o., the marketing authorisation holder for Vagifem 25 microgram vaginal tablets and Kliogest 2 mg/1 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to cease permanently the production of these medicines for the Croatian market. This decision has been taken due to commercial reasons and it is not associated with quality, efficacy or safe use of these medicines.

The batches of these medicines currently on the Croatian market, remain in the supply chain until they have been out of stock or they shelf live has expired.

There are other medicinal products containing the same active substances on the Croatian market, intended for hormone replacement therapy, with different strengths, though. Therefore, all patients using these medicines should consult their doctor about a change of medication.

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Dear Healthcare Professional Letter against off-label use of basiliximab (Simulect) in heart transplantations

09.09.2014

Novartis Croatia d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals to warn them against off-label use of basiliximab (Simulect) in heart transplantation.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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Information on production material imported from the Republic of Korea in 2013

08.09.2014

Based on the newly received information, upon the Customs Office reported about infliximab, imported from the Republic of Korea, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to provide information related to the production material from the Republic of Korea in 2013, that attracts great interest from the Croatian public and media and is being incorrectly associated to the revocation of the Zagreb Institute of Immunology’s manufacturing license.
There were no finished medicinal products or human vaccines to be used in Croatian patients, or any other alternative to products of the Zagreb Institute of Immunology, but an intermediate product for manufacturing , was imported, more precisely the active substance infliximab that has never been manufactured by the Zagreb Institute of Immunology. The biological substance infliximab is a monoclonal antibody used in manufacturing of a new generation so called “clever” biological medicines and cannot be in neither way associated with the products by the Zagreb Institute of Immunology, hence this manufacturer has never been producing neither this substance nor medicinal products or any other medicinal product intended to treat patients with the same indication as infliximab. Therefore, we are highlighting once again that the import of blood products from the Republic of Korea in 2013, that attracted great interest from the public, has not been associated with the revocation of the Zagreb Institute of Immunology’s manufacturing license.
The large amount of the active substance was not imported from the Republic of Korea to the Republic of Croatia for the Croatian healthcare system, but for the needs of the entire EU and it was imported in Croatia, because a part of the manufacturing process of this medicine for the whole EU takes place in Croatia.

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Dear healthcare professional letter on risks from thrombotic microangiopathy and nephrotic syndrome associated with the use of intereferon beta

08.09.2014

Medis Adria d.o.o., Bayer d.o.o., Novartis Croatia d.o.o. and Merck d.o.o. have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) send a letter to healthcare professionals on the risks from thrombotic microangiopathy and nephrotic syndrome associated with the use of interferon beta in treatment of multiple sclerosis.
Detailed information and the Deah Healthcare Professional Letter are accessible under the link below.

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