News and Educations

PRAC news – December 2013

06.12.2013

The Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicine’s Agency (EMA) gave new recommendations for the EU Member States on its meeting held in December 2013, concerning the safe use of medicines.
The PRAC has started an additional, in-depth review of benefits and risks associated with use of Iclusig in treating leukaemia. The review refers primarily to the risk of blood clots or blockages in the arteries or veins that is associated with the medicinal product.

The PRAC also concluded that the benefits of use of Kogenate Bayer and Helixate Nexgen, which are the second generation of factor VIII, continue to outweigh the risks in previously untreated patients with the bleeding disorder of haemophilia A.

Detailed information is available under the following link below.

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Dear Healthcare Professional Letter on the important changes to frequency of serum liver test monitoring for hepatotoxicity in patients treated with Votrient (pazopanib)

06.12.2013

The company Glaxo Smith Kline d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has sent a letter to healthcare professionals on the new, important recommendations related to frequency of serum liver test monitoring for hepatotoxicity i patients treated with pazopanib.

Detailed information and the Dear Healthcare Professional Letter are available under the following link below.

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Postgraduate continuous medical education course “Pharmacogenomics and pharmacovigilance – preventing adverse reactions in therapy individualisation – instructions and guidelines” now open for registration

02.12.2013

The postgraduate continuous medical education course “Pharmacogenomics and pharmacovigilance – preventing adverse reactions in therapy individualisation – instructions and guidelines” will be held on the 6 December 2013 at the CHC Rebro in Zagreb. The course is organised by the Zagreb University School of Medicine, Clinical Hospital Centre Zagreb and Agency for Medicinal Products and Medical Devices (HALMED).The course is for physicians of all specialties, doctors in primary care, pharmacists and other healthcare professionals.
The Committee for medical education of physicians of the Croatian Medical Chamber has categorised and valued the scientific conference with 7- for passive and 9 unit credits for active participation.
The Committee for continuous education of pharmacists of the Croatian Chamber of Pharmacists has assigned 3 credits to this scientific course.
The programme and additional information are available under the link below.

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Information about the recall of the medicinal product Kerasal ointment due to the expiration of the marketing authorisation

27.11.2013

The company Medical Intertrade d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of all batches of the medicinal product Kerasal ointment. The medicinal product is being recalled due to regulatory reasons. Pharmacies are advised to return the left over product stocks to wholesalers who distributed the product.
For more information please follow the link below.

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Workshop: Proactive pharmacovigilance and risk management in the era of individualised therapy

20.11.2013

The International Society of Pharmacovigilance (ISoP) and Agency for Medicinal Products and Medical Devices (HALMED) are organising a workshop entitled "Proactive pharmacovigilance and risk management in the era of individualised therapy” that will be held on 3 and 4 April 2014 in Zagreb.
The workshop is for representatives of competent authorities, pharmaceutical industry and academia.
For additional information about the workshop and registration for participation please follow the link below.

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Dear Healthcare Professional Letter about the haemophagocytic syndrome reported in patients treated with fingolimod (Gilenya)

15.11.2013

Novartis Europharm Limited, the marketing authorisation holder for the medicinal product Gilenya 0.5 mg hard capsules (fingolimod), has in collaboration with the Agency for Medicinal Products and Medical Devices sent out a letter to healthcare professionals about the two reported fatal cases of haemophagocytic syndrome in patients with multiple sclerosis (MS) treated with fingolimod.
For more information please follow the link below.

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Dear Healthcare Professional Letter about the introduction of new contraindications and warnings after cardiovascular safety assessment of diclofenac in the EU Member States

15.11.2013

Farmal d.d., Fresenius Kabi d.o.o., Krka – farma d.o.o, PharmaSwiss d.o.o., Pliva Hrvatska d.o.o. and Sandoz d.o.o., marketing authorisation holders for systemic formulations of diclofenac-containing medicinal products in the Republic of Croatia, have in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about important restrictions of use of diclofenac-containing medicinal products, following cardiovascular safety assessment in the EU Member States.

Detailed information and the Dear Healthcare Professional Letter are available under the link below.

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Dear Healthcare Professional Letter on the shortage of the medicinal product Pedea and information about an alternative treatment

15.11.2013

Orphan Europe, the marketing authorisation holder for the medicinal product Pedea 5 mg/ml solution for injection (ibuprofen), has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the interruption in the supply of the European market with this medicine. this is due to visible particles forming in the vials after production which has been detected only in bathes that have not been released on the market . It is estimated that the shortage will last by the end of 2013. This letter give further information to healthcare professionals about an alternative medicinal product unlicensed in the EU, but imported from the United States in agreement with HALMED and other competent authorities. The letter gives also advice to healthcare professionals regarding precautions to be used when prescribing the alternative unlicensed product in the EU for the indication concerned.

Detailed information and the letter are available under the link below.

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