Pharmacovigilance

Dear Healthcare Professional Letter on the risk of osteonecrosis of the jaw associated with use of denosumab (XGEVA): new contraindication and introduction of a patient reminder card to minimise the risk

30.10.2015

Amgen d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), would like to inform healthcare professionals of a new contraindication in patients with unhealed lesions from a dental or oral surgery and the introduction of a patient reminder card, to minimise the risk of osteonecrosis of the jaw during treatment with XGEVA (denosumab).

Further information and the Dear Healthcare Professional Letter are accessible here.

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Notice on the recall of three batches of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

14.10.2015

The Agency for Medicinal Products and Medical devices (HALMED) would like to inform on the recall of the batches B514AD and BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion of the marketing authorisation holder Medicuspharma d.o.o. from the Croatian market due to a suspected quality defect.

Further information is accessible under th elink bellow.

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Dear Healthcare Professional Letter on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib)

13.10.2015

Pfizer Croatia d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) would like to inform healthcare professionals on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib).

Further information and the Dear Healthcare Professional Letter is accessible under the link bellow.

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Recommendations for reporting variations in the medicine documentation based on the signal safety review from the PRAC September 2015 Meeting available now

09.10.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages the recommendations for reporting variations in the medicine documentation based on the safety signal review adopted on the September 2015 Meeting of the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Assessment Committee (PRAC) as well as Croatian translations of these recommendations. The recommendations concern the following active substances: alendronic acid, cholecalciferol, clodronic acid, etidronicl acid, ibandronic acid, neridronic acid, palmidronic acid, risedronic acid, tiludronic acid, zoledronic acid, leflunomide, thioctic acid and trabectedin. The recommendations are available in the Medicines/Instructions for MAHs regarding variation applications following PRAC recommendationsas safety signals Section.

When reporting a variation, marketing authorisation holders are obliged to use the adopted Croatian translation, whenever it is available and in this case, classify the variation as IAIN C.I.z. When submitting an application for variation, the marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.

When submitting an application for variation, the marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.

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