News and Educations

The Working Group on OTC Medicinal Products established

31.12.2009

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.

Publication of the Ordinance on Amendment to the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products

30.12.2009

The Ordinance on Amendment to the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products was published in the Official Gazette No. 155/09.

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.

Recall of two lots of the medicinal product BiCNU injection 100 mg

23.12.2009

The Agency for Medicinal Products and Medical Devices has recalled two lots of the medicinal product BiCNU injection 100 mg, the package containing 1 vial of powder and 1 vial or ampoule of diluent, in a box, their numbers being 9F54881 and 9D47031, of the manufacturer Bristol-Myers Squibb, due to suspected quality defect of these two lots of the medicinal product.

Presentation of a clinical trials manual intended for patients and their families

17.12.2009

The Clinical Trial - A Manual for Patients and their Families was promoted on Wednesday, 16 December 2009, in the Great Hall of the Andrija Štampar Institute of Public Health. The manual was prepared at the initiative of the publisher of the Coalition of Healthcare Sector Associations (KUZ) by Professor Dinko Vitezić, PhD, MD, president of the Central Ethics Committee.

Change to indication and dosage of the medicinal product with active substance oseltamivir (Tamiflu) in children below 12 months of age during the pandemic influenza

16.12.2009

The Agency for Medicinal Products and Medical Devices accepted the changes to the information on the medicinal product Tamiflu (oseltamivir). The changes are accepted for all approved pharmaceutical forms and doses of the medicinal product Tamiflu.

Newly approved medicinal products

10.12.2009

Here you can find a list of newly approved medicinal products between 1st November 2009 and 30th November 2009.

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.

A Dear Healthcare Professional letter to physicians about important information concerning administration of Relenza (zanamivir)

24.11.2009

GlaxoSmithKline (GSK), in collaboration with the Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional letter to physicians about important information concerning administration of the medicinal product Relenza (zanamivir).

Newly approved medicinal products

09.11.2009

Here you can find a list of newly approved medicinal products between 1st October 2009 and 31st October 2009.

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