News and Educations

Launch of the new subsection “Instructions for marketing authorisation holders about the readability and simplicity testing of the package leaflet” within the section “Documentation upgrading for medicinal products” of our website

15.03.2013

A new subsection “Instructions for marketing authorisation holders about the readability and simplicity testing of the package leaflet” has been launched on the webpages of the Agency for Medicinal Products and Medical Devices within the section “Documentation upgrading of medicinal products”.

Information about the shortage of the medicinal product Xyzal 0.5 mg/ml oral solution (levocetirizine)

15.03.2013

Medis Adria d.o.o., the marketing authorisation holder for the medicinal product Xyzal 0.5 mg/ml oral solution (levocetirizine), has informed the Agency for Medicinal Products and Medical Devices about the expected shortage of this product on the Croatian market. The shortage is due to a manufacturing delay.
The normalisation of the supply chain with the product is expected by the end of April 2013. Other medicinal products from the same therapeutic group are available on the Croatian market.

Information about the shortage of the medicinal product BCG-medac, powder and solvent for suspension for intravesicular use

15.03.2013

Medis Adria d.o.o., the marketing authorisation holder for the medicinal product BCG-medac, powder and solvent for suspension for intravesicular use, has informed the Agency for Mediocinal Products and Medical Devices about the unexpected shortage of this product on the Croatian market. The product is out of stock due to an increased demand.
The normalisation of the supply chain with BCG-medac, powder and solvent for suspension for intravesicular use is expected in October 2013 and a possibility of import of the product under the legal exemption scheme for treatment of patients is foreseen by then.

Dear Health Care Professional Letter about the recall of medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin) from the Croatian market

08.03.2013

Novartis Hrvatska d.o.o., the marketing authorisation holder for medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin), has i n collaboration with the Agency for Medicinal Products and Medical Devicesd (HALMED) sent out a letter to health care professionals about the new information associated with the use of calcitonin. Due to a risk of malignant diseases with a long term use of the product, Miacalcic 200 IU nasal spray, solution has been withdrawn from the market, whereas Miacalcic 100 IU/ml solution for injection has been withdrawn from commercial reasons.

You may view the the Dear Health Care professional Letter in the continuation of this information.

Import of medicinal products after the accession of the Republic of Croatia to the European Union

25.02.2013

Taking into account the soon access of the republic of Croatia to the EU and according to the Articles 40 and 51 of Directive 2001/83/EC, which Croatia has to transpose in its national legislation, the Agency for Medicinal Products and Medical Devices (HALMED) informs all holders of the wholesale license, holders of import/export license and marketing authorisation holders that the import of medicinal products from third countries in the Republic of Croatia may be carried out solely by physical or legal entities having a manufacturing license, that will according to the EU legislation be called “the importer”.
Further information you may find in the continuation of this information.

Recall of three batches of the medicinal product Oxaliplatin Pliva concentrate for solution for infusion (oxaliplatin)

22.02.2013

Three batches of the medicinal product Oxaliplatin Pliva, concentrate for solution for infusion (oxaliplatin) with batch numbers 12G12LM, 11A24KF and 12I14LJ, manufactured by Pliva Hrvatska d.o.o., Zagreb, Republic of Croatia that are suspected to have a possible quality defect are withdrawn from the Croatian market.
Further details about the recall of the batches, you may find in the continuation of this information.

List of medicinal products whose marketing authorisation has been suspended or withdrawn

15.02.2013

Here you can find the list of medicinal products whose marketing authorisation was suspended or withdrawn in the period from December 1 to December 31, 2012.

Newly approved medicinal products

15.02.2013

Here you can find a list of newly approved medicinal products between 1st December 2012 and 31st December 2012.

The European Medicines Agency has started a review of combined hormonal contraceptives containing chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate

08.02.2013

The European Medicines Agency (EMA) has started a review of several combined hormonal contraceptives that are authorised in the EU. Combined hormonal contraceptives contain two types of hormones, estrogen and progesterone (gestagen). This review includes all contraceptives containing the following gestagenes: chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin and norgestimate.

Detailed information you may find in the continuation of this information.

Press release of the European Medicines Agency about the beginning of the safety assessment of the medicinal product Diane 35 and its generics

08.02.2013

On 8th February 2013, the European Medicines Agency published a press release about the beginning of the safety review of the use of the medicinal product Diane 35 and its generics that we transmit in the continuation of this information.

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