News and Educations

New information on the possible interaction between clopidogrel and proton pump inhibitors

22.03.2010

Having analysed the new data, the European Medicines Agency (EMA) published a press release on the possible interaction between clopidogrel and proton pump inhibitors.

Newly approved medicinal products

09.03.2010

Here you can find a list of newly approved medicinal products between 1st February 2010 and 28th February 2010.

Head of the Agency gave a lecture at the Pharmacon conference in Belgrade on the ALMP experience with counterfeit medicines

02.03.2010

Head of the Agency, Assist. Prof. Siniša Tomić, PhD, gave a lecture at the Pharmacon conference on the ALMP's experience with counterfeit medicinal products. The conference was held in Belgrade on 25 February 2010.

Adverse drug reactions reporting - healthcare professionals and patients

26.02.2010

New forms for reporting adverse drug reactions (ADRs) to medicinal products and vaccines are available in the Forms section of the Agency for Medicinal Products and Medical Devices website.

In addition to the new forms for ADR reporting by healthcare professionals involving medicinal products and vaccines, there is, as per the Ordinance on the Pharmacovigilance (Official Gazette No. 125/09), also an ADR reporting form to be used by patients and sent directly to the Agency.

A Dear Healthcare Professional letter to physicians about the restricted supply of the medicinal product Fabrazyme (agalsidase beta)

26.02.2010

The marketing authorisation holder in the Republic of Croatia for Genezyme Corporation's medicinal products, Medical Intertrade d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices sent a Dear Healthcare Professional letter to prescribing physicians about the future restricted supply of Fabrazyme (agalsidase beta). The revised provisional treatment recommendations published in September 2009 are still valid.

Information on the medicinal product Avandia (roziglitazone)

22.02.2010

Warnings about the complications linked to cardiovascular diseases in patients taking the medicinal product Avandia (roziglitazone), which are currently a subject of debate in the USA, were issued by the Agency for Medicinal Products and Medical Devices back in 2007 and 2008, and consequently, in 2008, safety labeling revisions were made to the Summary of Product Characteristics (intended for healthcare professionals) and the Patient Information Leaflet (intended for patients).

Recall of a single lot of the medical device OneTouch GlucoTouch test band for measuring the blood glucose level

22.02.2010

Medical Device Registration Holder in Croatia, Johnson & Johnson S.E., d.o.o., informed the Agency for Medicinal Products and Medical Devices that a Field Safety Corrective Action was under way in connection with the lot no. 2982534 of the medical device OneTouch GlucoTouch test bands for measuring blood glucose levels of the manufacturer LifeScan Inc., USA.

Recall of a Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa) lot

10.02.2010

Due to suspected quality defect, the Agency for Medicinal Products and Medical Devices on 9 February 2010 recalled one lot (no. 09J26G11) of the medicinal product Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa), manufactured by Solvay Pharmaceuticals GmbH, Germany.

Newly approved medicinal products

09.02.2010

Here you can find a list of newly approved medicinal products between 1st January 2010 and 31st January 2010.

Publication of the new Ordinance on Clinical Trials and Good Clinical Practice

03.02.2010

Ordinance on Clinical Trials and Good Clinical Practice, which comes into effect on the eighth day after publication, i.e. on 6 February 2010, was published in the Official Gazette No. 14/2010.

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