News and Educations

"Dear Doctor Letter" on spotted error in the package information leaflet for M-M-RVAXPRO vaccin

23.03.2012

Merck Sharp & Dohme d.o.o. Company, which is the marketing authorisation holder for M-M-RVAXPRO medicinal product, has sent a "Dear Doctor Letter" in collaboration with the Croatian Agency for Medicinal Products and Medical Devices on the spotted error in the patient information leaflet. The text incorrectly rendered "in subcutaneous muscle" as the route of administration instead of the correct text "intramuscular or subcutaneous application."

Representatives of HALMED in the Netherlands at the workshop on reporting adverse reactions by patients

21.03.2012

Representatives of the Croatian Agency for Medicinal Products and Medical Devices participated from 7th to 9th March 2012 at the workshop on reporting of adverse reactions by patients which was held within the Monitoring Medicines Project organised by a consortium of organisations in the field of pharmacovigilance and led by World Health Organisation. The workshop was held in the City of 's-Hertogenbosch in the Kingdom of the Netherlands and hosted by the Dutch National Pharmacovigilance Centre – LAREB. An application adopted to patient needs for reporting of adverse reactions was presented within the workshop by Uppsala Monitoring Centre which is a collaborating centre of World Health Organisation.

Completion of the assessment of orlistat containing medicinal products

19.03.2012

European Medicines Agency has completed the assessment of anti-obesity medicines containing orlistat by which it considered that very rare cases of severe liver injury that have been reported may be linked to orlistat. However, EMA has concluded that the benefit of orlistat continues to outweight its risk.

Newly approved medicinal products

16.03.2012

Here you can find a list of newly approved medicinal products between 1st February 2012 and 29th February 2012.

Letter to health care professionals on the risk of accidental overdose during administration of the drug Perfalgan 10 mg/ml (intravenous paracetamol)

13.03.2012

The company PharmaSwiss d.o.o., marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml, in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED) has sent a letter to physicians regarding the risk of medication errors and the consequential accidental overdose in newborns and infants during the administration of the medicinal product Perfalgan 10 mg/ml. The letter also informs physicians of the risk of accidental overdose in all patients with body weight ≤50 kg and reminds of the currently valid dosage recommendations.

Letter to physicians about the interactions of the drug Victrelis (boceprevir) with ritonavir-enhanced protease inhibitors for HIV

12.03.2012

The marketing authorisation holder for the drug Victrelis 200 mg hard capsules (boceprevir), Merck Sharp & Dohme d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED) has sent a letter to physicians who prescribe Victrelis to inform them of new findings regarding interactions with ritonavir-enhanced protease inhibitors for HIV.

Letter to health care professionals about the market rerelease of specific series of the medicinal product Oxaliplatin Pliva

09.03.2012

The company Pliva Hrvatska d.o.o., marketing authorisation holder for the drug Oxaliplatin Pliva, in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent out a letter to health care professionals informing them of the market rerelease of the series 10C10QJ of the drug Oxaliplatin Pliva 50 mg/10 mL concentrate for infusion solution, and series 10J12PG, 11A18UD and 11A20NM of the drug Oxaliplatin Pliva 100 mg/20 mL concentrate for infusion solution.

Notification of voluntary recall of two series of the drug Ultraproct mast

08.03.2012

Important safety information on the risk of overdose with methotrexate for oral use

05.03.2012

Following up on the letter to physicians sent out in 2009, the Agency for Medicinal Products and Medical Devices (HALMED) is reminding prescribing physicians of the risk of overdose with methotrexate for oral use due to the incorrect daily application of the weekly dose in rheumatic and dermatological indications. Oral forms of methotrexate are not availabile in the Republic of Croatia, but are available to Croatian patients through imports.

Letter to health care professionals regarding the new contraindications and warnings for the use of medicinal products containing aliskiren in combination with angiotensin converting enzyme inhibitors or angiotensin receptor blockers

28.02.2012

The company Novartis Hrvatska d.o.o., marketing authorisation holder for the medicinal product Rasilez (aliskiren) and Rasilez HCT (aliskiren + hydrochlorothiazide), in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter to health care professionals regarding new contrarindications and warnings for the use of medicinal products containing aliskiren in combination with angiotensin converting enzyme inhibitors or angiotensin receptor blockers.

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