News and Educations

Newly approved medicinal products

23.09.2009

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

Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2008

26.08.2009

Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2008 was published by the Agency for Medicinal Products and Medical Devices on its website on 26 August 2008.

Newly approved medicinal products

24.08.2009

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

Updated information on supply of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta)

14.08.2009

Genzyme Corporation informed the European Medicines Agency (EMEA) that the supply shortage of the medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) would be more severe than initially expected. Consequently, EMEA's Committee for Medicinal Products for Human Use (CHMP) updated its temporary treatment recommendations.

Withdrawal of the Marketing Authorisation for Raptiva 100 mg/ml (efalizumab)

06.08.2009

Following the News issued by the Agency for Medicinal Products and Medical Devices on February 2009, the marketing authorisation of the finished medicinal product Raptiva 100 mg/ml (efalizumab) in the Republic of Croatia, has been withdrawn in accordance with the European Medicines Agency recommendation and the decision by the European Commission.

Additional information on safety of medicinal products containing insulin glargine as active substance

24.07.2009

Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine; and the risk of cancer, European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.

Extension of shelf life for Tamiflu 75 mg, 45 mg and 30 mg hard capsules

17.07.2009

The European Medicines Agency (EMEA) has recommended that the shelf life of Tamiflu capsules should be extended from 5 to 7 years. The Agency for Medicinal Products and Medical Devices approved this variation for all dosages of the Tamiflu hard capsules that have the marketing authorisation in the Republic of Croatia (Tamiflu 75 mg, 45 mg and 30 mg). The Summary of Product Characteristics, Medicinal Product Labelling and Patient Information Leaflet in all newly manufactured capsule series will be amended accordingly.

Newly approved medicinal products

08.07.2009

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

Newly approved medicinal products

07.07.2009

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

Dear Healthcare Professional Letter to physicians concerning safe use of Myfortic (mycophenolic acid)

06.07.2009

Novartis Hrvatska d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices, on 6 July 2009, sent a Dear Healthcare Professional Letter to prescribing physicians in order to inform them about the latest data on safe use of Myfortic 360 mg film-coated gastro-resistant tablets (mycophenolic acid).

For Patients and Public

For Health Care Professionals

For Industry Representatives