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.

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.

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.

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).

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).

Relenza (zanamivir) shelf-life extended

29.10.2009

The Agency for Medicinal Products and Medical Devices approved extension of expiry date for the medicinal product Relenza (zanamivir) Inhalation Powder from 5 to 7 years.

Dear Healthcare Professional Letter to physicians with important information concerning administration, and thereby safe use, of RELENZA (zanamivir)

29.10.2009

In cooperation with the Agency for Medicinal Products and Medical Devices, GlaxoSmithKline (GSK) sent a Dear healthcare professional letter to prescribing physicians with important information relating to the administration, and thereby the safe use, of the medicinal product Relenza (zanamivir).

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.

Publication of new Ordinance on Pharmacovigilance

23.10.2009

The new Ordinance on Pharmacovigilance was published on the 19th October 2009 in the Official Gazette No. 125/09.This Ordinance comes into effect on the eight day after its publication in the Official Gazette. The link to the Ordinance can be found on the ALMP website, in the Legislation section.

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