News and Educations

Dear Healthcare Professional Letter on the important information on stickers on vials as precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib)

03.12.2014

Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important information on stickers on vials as a precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

more

Dear Healthcare Professional Letter on the new information aimed at the safe use including the Pregnancy prevention programme for Erivedge 150 mg hard capsules (vismodegib)

03.12.2014

Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important safety information with regard to teratogenic effects of Erivedge 150 mg hard capsules (vismodegib) and introduction of the Pregnancy prevention programme for this medicine.

More information and the Dear Healthcare Professional letter is accessible under the link below.

more

CMDh News – November 2014

02.12.2014

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has endorsed new recommendations on testosterone-containing medicines, valproate – containing medicines and related active substances, continued with the implementation of the outcome of the referral for Tazocin and medicinal product with associated names. and endorsed the new version of the Core SmPC/PL.

More information is accessible under the link below.

more

Notice on the temporary discontinuation of distribution and use of the batch B514ADof Medoclav 1000 mg + 200mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

27.11.2014

Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation of distribution and use of the batch B514AD of this medicine from the Croatian market. The discontinuation procedure of distribution and use of this batch is carried out based on the quality defect reported from a healthcare professional about a different colour in two bottles from the same package.

The marketing authorisation holder has notified HALMED about other batches on the market that are available for treatment, so that the supply of the Croatian market will not be at risk.

More information is accessible under the link below.

more

Notice on the expected shortage of Propranolol Sandoz 40 mg tablets (propranolol)

25.11.2014

Sandoz d.o.o., the marketing authorisation holder for Propranolol Sandoz 40 mg tablets (propranolol) has notified the agency for Medicinal Products and Medical Devices (HALMED) on the expected shortage of this medicinal product on the Croatian market. The shortage is due to manufacturing or purchase problems of the active substance.

More information is accessible under the link below.

more

Pharmacovigilance Workshop: Risk Management, Electronic Reporting; XEVMPD updates

25.11.2014

The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates will be organised from on the 10 and 11 February 2015 in Zagreb.

Details on fees, venue of the workshop and registration are accessible in the registration form by which all interested participants may register. The workshop programme is accessible under the link below.

more

CHMP News – November 2014

24.11.2014

Ten new medicines have been recommended for approval among which two orphan medicinal products at the November 2014 meeting of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended extensions for indications for Inductos and Travatan and recommended a change in classification for the emergency contraceptive ellaOne. The CHMP concluded its review of Corlentor/Procoralan (ivabradine) and discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera.

More information is accessible under the link below.

more

European Medicines Agency released recommendations on the classification status of ellaOne

21.11.2014

The European Medicines Agency (EMA) on its webpages has published a press release on the recommendations that will be forwarded to the European Commission for final Decision concerning the classification status of ellaOne. The entire press release is accessible below.

more

Dear Healthcare Professional Letter on exfoliative dermatitisan and skin exfoliation in patients treated with ustekinumab (Stelara)

21.11.2014

Janssen in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) has sent a letter to healthcare professionals on the risk from exfoliative dermatitis in patients treated with uskelimumab (Stelara).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

more

Expert Workshop “OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” held in Zagreb

21.11.2014

The Expert Workshop “OTC Medicines: the Role of Good Classification Practices in Promoting Medication Safety and Accessibility of in Europe” was organised by the European Directorate for the Quality of Medicines and Health Care (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) from 20 to 21st November 2014 in Zagreb. Almost hundred participants from national and European competent authorities for medicines, healthcare professionals, patient organisations and pharmaceutical industry from even 19 countries involved in classification of medicines as regard their supply took part in the workshop.

Details are accessibe under the link below.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives