News and Educations

Notice on the reported suspected adverse reactions to the Tetanus Vaccine, Institute of Immunology d.d. in Bosnia & Herzegovina

31.12.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has been notified by the Agency for Medicinal Products and Medical Devices of Bosina & Herzegovina (ALMBiH) about five reported suspected adverse reactions after the use of the Tetanus Vaccine (adsorbed), Institute of Immunology, batch 78/3 with the expiry date by August 2015. The tetanus vaccine is indicated for stimulating the active immunity against tetanus.

The Agency for Medicinal Products and Medical Devices B&H has concluded that the benefits/risks ratio for this vaccine remains positive. According to HALMED’s data, the Tetanus Vaccine manufactured by Institute of Immunology d.d., including this batch is not on the Croatian market.

More information is accessible under the link below.

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HALMED celebrates 40 years of spontaneous adverse reaction reporting in Croatia

24.12.2014

The Republic of Croatia celebrates this year forty years of spontaneous suspected adverse reaction reporting. On this occasion that is important for monitoring the safe use of medicines, the Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages a number of informative texts posted in the occasional section “40 years of spontaneous ADR reporting in Croatia” to make users and patients more familiar with the importance and procedures of suspected adverse reaction reporting as well as with the system of monitoring the safe use of medicines in Croatia.

The new section is available in the Pharmacovigilance/40 years of spontaneous reporting in Croatia section of the HALMED's webpages. More information is accessible under the link below.

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New version of Web offers application now available on the HALMED webpages

23.12.2014

The new version of the Web offers application is now available on the HALMED pages. This version is made based on the recommendations from HALMED’s users and it offers, among others, a possibility to create group offers for payment of group variations.

With the new version of this application, users may create offers as unregistered users as before, or may register, or open an account providing additional benefits for use such as: tabular display of previous offers with relevant data, created for their company, browsing through offer status, browsing through details of offer realisation, browsing possibility of offers in pdf format, creation of new offers based on the existing one and enter of additional notes and commentaries for personal evidence. In order to facilitate browsing of already created offers by now to registered users, the tabular display provides filtering and grouping of offers against columns.

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Dear Healthcare Professional Letter about the risks of hypogammaglobulinaemia and bronchiectasis associated with the use of mycophenolate mofetil & mycophenolic acid

19.12.2014

Roche d.o.o., Sandoz d.o.o., Alpha-medical d.o.o., Novartis Croatia d.o.o. and Pliva Croatia d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would to inform healthcare professionals about the risks of hypogammaglobulinaemia and bronchiectasis associated with the use of mycophenolate mofetil & mycophenolic acid.

More information and the Dear Healthcare Professional Letter are accessible under the link below.

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Regulatory Affairs Workshop

18.12.2014

The Agency for Medicinal Products and Medical Devices (HALMED) organises a one day workshop entitled “Regulatory Affairs Workshop” intended to marketing authorisation holders which will be held on 6 February 2015, from 9 a.m. to 4 p.m. in Zagreb. It is one of the numerous similar workshops organised in 2013 and therefore we would like to invite all interested individuals who have not attended similar workshops as well as those wishing to broaden their knowledge in the field to register. The workshop will be held at the HALMED’s premises, Robert Frangeš Mihanović Street 9 (Sky Office Business Building), 1st Floor, Zagreb.

More information is accessible under the link below.

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Notice on reintroducing the batch of Glucose 10% Viaflo solution for infusion on the market

17.12.2014

Following to the Notice on temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate) of the marketing authorisation holder, Agmar d.o.o., published on 31 October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the reintroducing of the batch 14C17E3M of this medicine on the Croatian market.

More information is accessible under the link below.

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Dear Healthcare Professional Letter on the risk of abnormal pregnancy outcomes associated with the use of valproate (Depakine Chrono)

16.12.2014

Sanofi-aventis Croatia d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the risk of abnormal pregnancy outcomes associated with the valproate use (sodium valproate, valproic acid, fixed combination sodium valproate/valproic acid and valpromid are concerned), upon completion of the review of the available data in the entire Europe.

More information and the Dear Healthcare Professional Letter are accessible under the link below.

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