Pharmacovigilance

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.

Pharmacovigilance Workshop: Risk Management; Electronic reporting; XEVMPD updates

30.12.2014

The Pharmacovigilance Workshop: Risk Management, Electronic reporting, XEVMPD updates will be held from 10 to 11 February 2015 in Zagreb.

All who are interested may register via the registration form which is accessible under the link below.

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.

CHMP News – December 2014

22.12.2014

Seven new medicines have been recommended for marketing authorisation, extensions of indications for four medicines have been recommended and the GVK Biosciences review has been updated at the December 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP).

More information is accessible under the link below.

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.

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.

Dear Healthcare Professional Letter on recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding

16.12.2014

Eli Lilly Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding.

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

Dear Healthcare Professional Letter on new contraindications and recommendations for minimising risks from cardiovascular events and severe bradycardia associated with the use of Procoralan and Corlentor (ivabradine)

10.12.2014

Servier Pharma d.o.o., the local marketing authorisation holder’s representative for Procoralan and Corlentor (ivabradine), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommendations for use of ivabradine to minimise the risk from cardiovascular events and severe bradycardia.

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

Dear Healthcare Professional Letter on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride)

09.12.2014

Bracco International BV, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform health care professionals on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride).

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

Dear Healthcare Professional Letter on the case of progressive multifocal leukoencephalopathy in Tecfidera (dimethyl fumarate) treated patient with severe and prolonged lymphopenia

04.12.2014

In agreement with the agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), Medic Adria d.o.o. is sending a letter to healthcare professionals on the important safety information with regard the case of progressive multifocal leukoencephalopathy (PML) associated with the use of Tecfidera for the treatment of multiple sclerosis.
More information and the Dear Healthcare Professional Letter are accessible under the link below.

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