News and Educations

The Working Group on OTC Medicinal Products established


At the proposal of pharmaceutical companies, and in conformity with Articles 17 and 18 of the Statute of the Agency for Medicinal Products and Medical Devices, the Head of the Agency passed a decision to establish the Working Group on OTC Medicinal Products. The members of the Working Group include the representatives of the Agency, the Croatian Chamber of Pharmacists, the Croatian Pharmaceutical Society, certain companies, patients' associations and domestic and international pharmaceutical associations.


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


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.


Safe use of medicinal products containing active substance valproate


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.