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News

In collaboration with the Mala scena theatre, HALMED promotes the importance of rational use of medicines and reporting of suspected adverse reactions 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 re-marketing of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)
24.02.2015.

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has not been confirmed, the temporary interruption of distribution and use of the batch HC 68E of this medicine has been revoked, and the existing stock can be dispensed and used again.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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PRAC News – February 2015
13.02.2015.

At its February 2015 meeting, the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) adopted recommendations regarding heart risks associated with use of hydroxyzine-containing medicines.

More information 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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MRP i DCP postupci
Croatian Pharmacopoeia
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Events - HALMED

Rovinj, 21-24 May 2015
5th Croatian Congress on Pharmacy with International Participation

The Croatian Pharmaceutical Society organises in collaboration with the Faculty of Pharmacy and Biochemistry and the Agency for Medicinal Products and Medical Devices (HALMED) the 5th Croatian Congress on Pharmacy with International Participation that will be held from 21 to 24 May 2015 in Rovinj.

More information is accessible under the link below.

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Educational course “Distribution of medical devices”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.

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Educational course “Introduction to medical devices vigilance”

The educational course “Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
More information is available in the continuation of this information.

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