Pharmacovigilance

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.

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).

Safe use of thionamide class of medicinal products

05.06.2009

The U.S. Food and Drug Administration (FDA) reported on the new data indicating increased hepatotoxicity associated with the medicinal products containing propilthiouracile as active substance. It should be emphasised that no conclusion has been reached regarding the cause-effect relationship and that the FDA's information ought not to be interpreted as a recommendation to discontinue the treatment with propilthiouracile.

Potential interaction between clopidogrel and proton pump inhibitors

05.06.2009

The European Medicines Agency (EMEA) published a statement on potential interaction between clopidogrel and proton pump inhibitors. In patients simultaneously taking clopidogrel and a proton pump inhibitor, the effect of clopidogrel may be reduced, which may result in an increased risk of, for instance, heart attack and cerebral thrombosis, or the coronary stent and bypass thrombosis.

Dear Healthcare Professional Letter on new information regarding the safety of Tarceva (erlotinib)

25.05.2009

In cooperation with the Agency for Medicinal Products and Medical Devices, on 25 May 2009, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians regarding the new information on safety of Tarceva film tablets (erlotinib).

Safe use of antiepileptic medicines

06.05.2009

The U.S. Food and Drug Administration (FDA) announced the end of a review of a group of antiepileptic medicines and recommendations regarding the safety of their use.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia will approve amendments to the medicinal product information (Summary of Product Characteristics, Patient Leaflet) for the above group of medicines and continue to closely monitor the safety of this group of medicinal products.

Important safety information on methotrexate dosage

21.04.2009

The Agency for Medicinal Products and Medical Devices sent a letter to healthcare professionals with important safety information on methotrexate dosage for oral use when indicated for treatment of psoriasis and rheumatoid arthritis.

A letter to physicians regarding the safe use of Yasmin

25.03.2009

In collaboration with the Agency for Medicinal Products and Medical Devices, on 25 March 2009, Bayer d.o.o. sent a letter to gynecology and dermatology specialists regarding the changes in the information on use of Yasmin (drosperinonum, ethinylestradiolum).

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