News and Educations

Information about printing error in the package leaflet of certain batches of Xeloda

16.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a quality defect report for Xeloda (capecitabine). This is due to a printing error in the package leaflet of certain batches of Xeloda.
In the paragraph 1 of the package leaflet “What is Xeloda and what is it used for”, there is an incorrect statement that the medicine contains 150 mf of capecitabine instead of 500 mg capecitabine. The affected batches containing the correct amount of 500 mg of capecitabine per tablet, which ia clearly stated in other parts of the package leaflet and labelling. The following batches have been affected by this quality defect , which means a printing error: B3010B02, B3024B03, X3197B05, X3164B02, X3111B02, X3048B02 and B3038B04.
Detailed information is accessible under the link below.

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Dear healthcare professionals letter on reminder on the Procoralan/Corlentor conditions of use for the symptomatic treatment of chronic stable angina pectoris to avoid potentially dangerous bradycardia

12.06.2014

Servier Pharma d.o.o., local representative of the marketing authorization holder, in collaboration with the Croatian Agency for Medicinal Products and Medical Devices, have sent a letter to healthcare professionals on the emerging safety issue for Procoralan/Corlentor (ivabradine). Preliminary results of the SIGNIFY study have shown a small but statistically significant increase in the combined risk of cardiovascular death and non-fatal myocardial infarction with ivabradine compared with placebo in a pre-specified subgroup of patients with symptomatic angina of CCS class II or more.
Initial data indicate that the adverse cardiovascular outcomes may be mostly associated with the target heart rate being below 60 bpm; however data from the SIGNIFY study are being further evaluated to fully understand its implications for the clinical use of ivabradine.

HALMED encourages health care professionals to strictly adhere to the approved indication of ivabradine, as well as any restrictions on the use of ivabradine listed in the summary of product characteristics, until the outcomes of the assessment are known. In case of any concerns, patients who were treated with ivabradine should contact their doctor for advice.

Detailed information is accessible under the link below.

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Information about the recall of Soliris 300 mg concentrate for solution for infusion

05.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received via rapid alert system from the Italian Medicines Agency the information that Alexion Europe SAS-France, the marketing authorisation holder for Soliris 300 mg concentrate for solution for infusion (eculizumab), has started a preventive recall procedure of certain batches of this medicinal product.
A recall procedure is being currently carried out from the healthcare settings in the Republic of Croatia where batches No 00017D, 00021C, 00023C,00024C and 12SOL2D, manufactured by using the Pall component, have been distributed.
Detailed information is available under the link below.

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Lecture about the Cochrane collaboration strategy

04.06.2014

A lecture was hold today at the premises of the Agency for Medicinal Products and Medical Devices (HALMED) by Mark Wilson, the executive director of the Cochrane collaboration. The lecture presented the audience the Cochrane collaboration strategy by 2010, emphasizing especially the changes relating to submission of articles and systemic reviews, by which the Cochrane collaborators assist citizens in making informed decisions about their help.
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EudraVigilance Workshop – Electronic reporting of Individual Case Safety Reports in the European Economic Area

04.06.2014

An EudraVigilance workshop on the electronic Individual Case Safety Reports reporting in the European Economic Area will be held from 17 to 19 September 2014 in Zagreb, organised by Drug Information Association (DIA) and the European Medicines Agency (EMA). The workshop will be held at the HALMED premises, Robert Frangeš Mihanović Street 9 (Sky Office Business Building).
Detailed information is accessible under the link below.

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Notice about temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)

03.06.2014

GlaxoSmithKline d.o.o., marketing authorisation holder for Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), has upon request of the Agency for Medicinal Products and Medical Devices (HALMED) carried out a procedure of temporary distribution and use interruption of the batch AHBVC 262CD of this medicine.
The procedure of temporary distribution and use interruption of this batch of the medicine has been initiated as a caution measure, due to a suspected quality defect reported from a healthcare professional. The suspected quality defect consists in the change in appearance of the medicine (less milky than usual) and presence of precipitate particles that do not dissolve by remaining at the room temperature.
Detailed information is accessible under the link below.

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Information about counterfeit Herceptin (trastuzumab) on the Czech market

26.05.2014

Following the previous information about the counterfeit Herceptin (trastuzumab) on the EU market, the Agency for Medicinal Products and Medical Devices (HALMED) has been informed about a suspected counterfeit Herceptin on the Czech market.
In the Czech Republic, a medicinal product was found to have different labelling of the expiry date and batch number on the inner and outer packaging and to be labelled in different languages. The inner package was labelled with the batch number H0758, whereas indicated batch number on the outer packaging was H4342B01. The inner packaging and the package leaflet were prepared in Romanian and Bulgarian, whereas the outer packaging was prepared in Romanian language.
Detailed information is accessible under the link below.

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Information on recall of falsified Norditropin SimpleXx 10 mg/1,5 ml solution for injection (somatropin) on the German market

23.05.2014

The Agency for Medicinal Products and medical Devices (HALMED) has received the information about a falsified Morditropim SimpleXx 10 mg/1,5 ml solution for injection (somatropin), used for growth failure and disorders on the German market. A falsified batch of the medicine has been discovered, batch No LL38548, shelf life 10/2015, that has never been released by the manufacturer, Novo Nordisk A/S, Denmark. This falsified medicine is suspected to be purchased in an illicit distribution chain in Germany.
Further information is accessible under the link below.

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