News and Educations

Notice on re-marketing of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)

23.02.2015

Further to the Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan), published on 18 July 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about re-marketing of the said batch.

The procedure of temporary interruption of distribution and use of the said batch was launched as a precautionary measure due to a suspected quality defect report on the discovered turbid solution received by healthcare professionals.

Since based on the investigation the quality defect has not been confirmed, the temporary interruption of distribution and use of the batch HC 68E of this medicine has been revoked, and the existing stock can be dispensed and used again.

More information is accessible under the link below.

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In collaboration with the Mala scena theatre, HALMED promotes the importance of rational use of medicines and reporting of suspected adverse reactions

20.02.2015

Under the auspices and scientific support of the Agency of Medicinal Products and Medical Devices (HALMED), yesterday at 7 p.m. in the Mala scena theatre the premiere of the play “No, not you! or about differences” took place. The play is about the stigma of patients affected with epilepsy and ways to cope with this disease.

The play is primarily intended for school children and young and represents only one of the aspects of co-operation between HALMED and the Mala scena theatre aimed at promoting the importance of rational use of medicines and suspected adverse reactions reporting. Alongside leaflets on adverse reactions reporting that are distributed to spectators at every performance, a pedagogical material is also prepared that supplements the production and enables the continuation of dialogue after the play has been seen, and contains the information on adverse reactions and their reporting.

More information on the play and play schedule is accessible under the link below.

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Notice on interruption in the supply chain of the Diphtheria, tetanus, pertussis (acellular, component), BCG vaccine, Rabies vaccine prepared in human diploid cell cultures

13.02.2015

The Agency for Medicinal Products and Medical Devices (HALMED), as the competent authority for monitoring the supply of the Croatian market with medicines is informing all wholesale license holders about the notification from the Croatian Public Health Institute (CPHI) on the need of emergent procurement of Diphtheria, tetanus, pertussis (acellular, component) and BCG vaccine that are part of the Obligatory vaccination programme and Rabies vaccine prepared in human diploid cell cultures.

HALMED is, therefore, according to necessary public health measures, inviting all wholesalers to collect in the shortest time possible all information on the availability of these vaccines in other countries with the aim to ensure an adequate supply of the Croatian market by using the interventional enter/import, based on the HALMED’s consent. All collected data as well as contact detailed for individual wholesalers will be forwarded to CPHI by HALMED.

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Notice on discontinuation of the supply chain with Reglan 10 mg/2 ml solution for injection (metoclopramide)

12.02.2015

Alkaloid d.o.o., the marketing authorisation holder for Reglan 10 mg/2 ml solution for injection (metoclopramide) has notified the Agency for Medicinal Products and Medical Devices on the permanent discontinuation of the supply chain with this medicinal product. The decision on discontinuation of the supply chain is due to commercial reasons and is not linked with the quality, efficacy or safe use of the medicinal product.

There is no other authorised medicinal product with the same dosage form containing this active substance and HALMED will, at wholesaler’s request, for treatment of patients in healthcare settings or in the case of named patient prescriptions authorise the enter of medicinal products not authorised in Croatia.

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Important notice on obligation of reporting medicines consumption data to HALMED

12.02.2015

Under Medicinal Products Act (Official Gazette 76/13, 90/14) and Ordinance on type of data and procedure for creating reports on medicines consumption (Official Gazette 122/17), all natural and legal entities involved in wholesale of medicinal products and legal or physical entities involved in retail of medicinal products are obliged to report to HALMED at least once a year data on medicines consumption.

More information is accessible under the link below.

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HALMED takes over the BEMA Secretariat in the next cycle

09.02.2015

At the joint plenary meeting of the Heads of Medicines Agencies (HMA) it was decided that HALMED would take over the Secretariat of the Benchmarking of European Medicines Agencies in the EEA. The allocation of this important role to HALMED confirms its competencies.
Just to remind that in the last BEMA cycle, HALMED obtained the highest number of excellent (5) marks among all evaluated medicines agencies by now and many HALMED’s business indicators are considered to be the best practice at the EU level.

More informatuion is accessible under the link below.

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Notice on quality defect of the batch 3055005A of Cadil 25 mg tablets and the batch 4242001B of Excita 10 mg film-coated tablets

06.02.2015

Farmal d.d., the marketing authorisation holder for Cadil 25 mg tablets and Excita 10 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the discovered quality defect of the batch 3055005A of Cadil 25 mg and batch 4242001B of Excita 10 mg.

The concerned batches are placed on the Croatian market with an obligation to provide a written note on this quality defect to pharmacies.

More information is accessible under the link below.

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