Medicinal Products

New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya (fingolimod)

18.12.2015

The European Medicines Agency (EMA) has issued new advice for doctors and patients on the potential risks related to the immunosuppressive effect of the multiple sclerosis medicine Gilenya (fingolimod).

PRAC News - December 2015

04.12.2015

Direct healthcare professional communication on the strengthened advice for pregnancy prevention when using mycophenolic acid/mycophenolate mofetil/mycophenolate sodium: CellCept, Mikofenolat Stada, Mikofenolat Genera, Myfortic, Trixin

02.12.2015

Roche d.o.o., Stada d.o.o., Genera d.d., Novartis Hrvatska d.o.o. and Pliva Hrvatska d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals about the strengthened advice for pregnancy prevention when using mycophenolic acid, which is also available in authorised medicinal products as pro-drug mycophenolate mofetil, as well as in the form of mycophenolate sodium.

Direct healthcare professional communication on the risk of hepatotoxicity related to use of Ketaconazole HRA (ketoconazole)

02.12.2015

Laboratoire HRA Pharma, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals about important safety information in relation to Ketoconazole HRA, authorised for the treatment of endogenous Cushing’s syndrome in adults and adolescents above 12 years.

Direct healthcare professional communication on new measures to minimise the risk of PML with Tecfidera (dimethyl fumarate)

26.11.2015

Biogen Idec Ltd, in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of new important measures to minimise the risk of progressive multifocal leukoencephalopathy (PML) with Tecfidera.

CHMP News - November 2015

20.11.2015

Notice on expected shortage of Cefepime Kabi powder for solution for injection or infusion (cefepime)

16.11.2015

Fresenius Kabi d.o.o., the marketing authorisation holder for Cefepime Kabi powder for solution for injection or infusion (cefepime) à 1 and 2 g, has notified the Agency for Medicinal Products and Medical devices (HALMED) of an expected shortage of these medicinal products on the Croatian market.

Notice on expected shortage of Megostat 40 mg/ml oral suspension (megestrol)

16.11.2015

PharmaSwiss d.o.o., the marketing authorisation holder for Megostat 40 mg/ml oral suspension (megestrol), has notified the Agency for Medicinal Products and Medical Devices (HALMED) of an expected shortage with this medicine on the Croatian market.

For Patients and Public

For Health Care Professionals

For Industry Representatives