News and Educations

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.

Newly approved medicinal products

12.10.2009

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

Publication of the new Ordinance on Advertising of Medicinal Products and Homeopathic Medicinal Products

06.10.2009

New Ordinance on Advertising of Medicinal Products and Homeopathic Medicinal Products was published on 30 September 2009 in the Official Gazette of the Republic of Croatia No. 118/09. This Ordinance will come into effect on the eighth day from the date of the publication in the Official Gazette. The link to the Ordinance can be found at the ALMP website, in the Legislation section.

Information on safe use of medicinal products containing sitagliptine as the active substance

05.10.2009

U.S. Food and Drug Administration (FDA) issued a press release informing the public about the reports of cases of acute pancreatitis in patients receiving the medicinal products containing sitagliptine as the active ingredient.

Dear Healthcare Professional Letter to physicians concerning supply shortage of Fabrazyme (agalsidase beta) with revised temporary treatment recommendations

29.09.2009

The marketing authorisation holder in the Republic of Croatia for Genezyme Corporation's medicinal products, Medical Intertrade d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices sent a letter to prescribing physicians concerning supply shortage of Fabrazyme (agalsidase beta). The letter contains the new, revised temporary treatment recommendations compared to those published in July 2009.

5th EGA South East Europe Pharmaceutical Symposium

25.09.2009

The 5th EGA South East Europe Pharmaceutical Symposium, organised by the European Generic Medicines Association (EGA) and the Ministry of Health and the Bureau for Medicinal Products of the Republic of Macedonia, has started. The Conference takes place on 24-25 September 2009 in Ohrid, bringing together the regulatory authorities and generic drug manufacturers from the South East European countries.

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