Pharmacovigilance

Important notice concerning safety of medicinal products containing the active substance bufexamac with recommendations for physicians, pharmacists and patients

01.06.2010

The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revocation of marketing authorisation for all medicinal products containing the active ingredient bufexamac. Based on the CHMP's opinion, the European Commission will issue final recommendations for the medicinal products containing the aforementioned active substance.

The Agency for Medicinal Products and Medical Devices (HALMED) initiated the review process for the EMA's recommendation, issuing the recommendations for physicians, pharmacists and patients.

Notice concerning the shorter shelf-life of Act-HIB, vaccine against Haemophilus influenzae type B, Vaccinum haemophili stirpe b coniugatum, Lot D0636-3

01.06.2010

In collaboration with the Agency for Medicinal Products and Medical Devices, on 31 May 2010, Medoka d.o.o. sent a notice to the Croatian National Institute of Public Health, all County Institutes of Public Health, Institute of Immunology (warehousing and distribution of vaccines from the Vaccination Programme) and vaccinators, advising them of the shorter shelf life of Act-HIB, vaccine against Haemophilus influenzae type b, Lot: D0636-3.

Notice on suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5mg and 50 mg extended-release suspension for injection for intramuscular use

24.05.2010

The company Johnson & Johnson S.E. d.o.o., in collaboration with the Croatian Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional letter about the suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5mg and 50 mg extended-release suspension for injection for intramuscular use.

A Dear Healthcare Professional letter to physicians on the relationship of hypersensitivity and infusion reactions to the treatment with bevacizumab (Avastin®)

29.04.2010

Roche d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices, on 29 April 2010, sent a Dear Healthcare Professional letter to prescribing physicians on new safety data for AVASTIN 25 mg/ml concentrate for solution for infusion (bevacizumabum).

Recall of four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, of the manufacturer Baxter AG, Austria

15.04.2010

The Agency for Medicinal Products and Medical Devices recalled four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, the lots in question being VNC1J011-AA, VNC1J011-AB, VNC1J011-AC, and VNC1J011-AD, of the manufacturer Baxter AG, Austria, due to a suspected quality defect.

Additional information on Rotarix vaccine

26.03.2010

The European Medicines Agency (EMA) at a special meeting of its Committee for Medicinal Products for Human Use held on 25 March 2010 concluded that the unexpected presence of the DNA fragments of a non-pathogenic virus strain in two lots of the oral vaccine Rotarix did not represent any public health concern and that no restrictions need to be put in place in connection with the use of this vaccine.

Press release concerning the new information on Rotarix vaccine

23.03.2010

The European Medicines Agency (EMA) issued a press release concerning the new information provided by GlaxoSmithKline Biologicals, manufacturer of Rotarix vaccine. The information concerns unexpected presence of porcine circo virus type 1 DNA (non-pathogenic virus strain) in two lots of the vaccine. This vaccine is often found in meat and other food products and it is not known to cause any disease in animals or in humans.

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.

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).

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