News and Educations

Dear Healthcare Professional Letter to physicians concerning the supply shortage of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) and consequent temporary treatment recommendations

01.07.2009

Medical Intertrade d.o.o., the marketing authorisation holder of the Genzyme medicinal products in the Republic of Croatia, in cooperation with the Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional Letter to prescribing physicians concerning the supply shortage of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) and consequent temporary treatment recommendations.

Publication of the new Ordinance on Medical Devices Vigilance System

01.07.2009

The new Ordinance on Medical Devices Vigilance System was published on 29 June 2009 in the Official Gazette of the Republic of Croatia, No. 74/09. The 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 in the Legislation section of the ALMP website.

Publication of the new Ordinance on the Conditions and Procedure for Determining Good Manufacturing Practice Requirements and the Procedure for Issuance of Manufacturing Licence and the Good Manufacturing Practice Certificate

01.07.2009

The new Ordinance on the Conditions and Procedure for Determining Good Manufacturing Practice Requirements and the Procedure for Issuance of Manufacturing Licence and the Good Manufacturing Practice Certificate was published on 29 June 2009 in the Official Gazette, No. 74/09. The Ordinance will come into effect on the eighth day from the date of the publication in the Official Gazette. The link to this Ordinance can be found in the Legislation section of the ALMP website.

Safety of medicinal products containing insulin glargine as active substance

30.06.2009

The European Medicines Agency (EMEA) issued a press release concerning the safety of the medicinal products containing insulin glargine as active substance, in connection with the recently published registry studies investigating a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer.

Dear Healthcare Professional Letter concerning introduction of a pregnancy risk reduction plan for patients using CellCept

24.06.2009

On 24 June 2009, in cooperation with the Agency for Medicinal Products and Medical Devices, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians concerning implementation of the pregnancy risk reduction measures during use of CellCept (mofetilmycophenolate).

No change on safety profile of stimulant medication used in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

19.06.2009

The U.S. Food and Drug Administration (FDA) reported that no conclusions can be drawn regarding the change of the safety profile of this class of medicinal products from the results of the recently published study which, based on 10 cases, established an association between sudden death and the use of stimulant medications to treat children and adolescents with ADHD.

Safety information for medicinal products containing cefepime as active substance

18.06.2009

The U.S. Food and Drug Administration (FDA) informed about the completion of the assessment procedure for possible increased risk of higher mortality in patients using cefepime. The conclusion was that there were no data indicating increased mortality of patients treated with cefepime in comparison with those treated with other similar medicinal products. Cefepime remains an appropriate therapy for use in approved indications.

Dear Healthcare Professional Letter on restricted use of Nolicin 400 mg film tablet (Norphloxacin)

17.06.2009

Krka - farma d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional Letter to physicians concerning restriction of indications for use of the Nolicin 400 mg film tablet (norphloxacin) in line with the recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency of July 2008.

Warning on purchase of antivirals without a prescription

09.06.2009

The Agency for Medicinal Products and Medical Devices of the Republic of Croatia received a notification from the World Health Organisation (WHO) warning the public not to purchase antiviral medicinal products against the A/H1N1 influenza unless they are prescribed by a physician.

Recommendations of the Agency for Medicinal Products and Medical Devices on the use of Tamiflu in children under one year of age and the use of Tamiflu and Relenza in pregnant and breastfeeding women in the influenza A/H1N1 pandemic

09.06.2009

In connection with the recent outbreak of the A/H1N1 influenza, the Committee for Medicinal Products of the Agency for Medicinal Products and Medical Devices, at its 111th session, adopted the recommendations for use of antiviral medicine Tamiflu (oseltamivir) in children under one year of age, and the medicinal products Tamiflu and Relenza (zanamivir) in pregnant and breastfeeding women in the case of a declared influenza A/H1N1 pandemic (The World Health Organization has raised its pandemic alert level for the A/H1N1 influenza virus to phase 6). The recommendations are harmonised with the recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

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