Pharmacovigilance

The Report of the Agency for Medicinal Products and Medical Devices and the European Medicines Agency on adverse reactions to the pandemic vaccine Focetria

28.12.2009

The Agency for Medicinal Products and Medical Devices, together with the Croatian National Institute of Public Health, collects and analyses adverse reactions to all vaccines. In the period since the start of the vaccination campaign with the vaccine Focetria (from 27.11. until 28.12.2009.), two adverse reaction reports have been received. Both these reports related to mild and known adverse reactions that were stated in the Patient Information Leaflet.

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Safe use of medicinal products containing active substance valproate

04.12.2009

The U.S. Food and Drug Administration reported an increased risk of birth defects in children whose mothers had been taking valproic acid during the pregnancy. There is an increased risk of neural tube defects and other major birth defects, such as craniofacial defects or cardiovascular malformation in children exposed to valproate-sodium and similar medicinal products (valproic acid and divalproex-sodium) during the pregnancy.

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A Dear Healthcare Professional letter to physicians about important information concerning safety of the medicinal product MabThera (rituximab) in treatment of patients with rheumatoid arthritis

09.11.2009

Roche d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices, on 9 November 2009, sent a Dear Healthcare Professional letter to prescribing physicians about MabThera (rituximab) and progressive multifocal leukoencephalopathy (PML) in treatment of patients with rheumatoid arthritis (RA).

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Dear Healthcare Professional Letter to physicians concerning supply of Cerezyme (imiglucerase) with revised temporary treatment recommendations

27.10.2009

The holder of the marketing authorisations for the medicinal products of Genezyme Corporation in Croatia, the company Medical Intertrade d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices sent a letter to prescribing physicians in connection with restricted supply of Cerezyme (imiglucerase). The letter contains new, revised temporary treatment recommendations in relation to those published in August 2009.

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