News and Educations

Information about the interruption in manufacturing and supply chain with Sodium Hydrogen Carbonate Pliva 84 mg/ml solution for infusion

03.03.2014

The marketing authorisation holder for Sodium Hydrogen Carbonate Pliva 84 mg/ml solution for infusion, Pliva Hrvatska d.o.o., has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the interruption in manufacturing and supply chain of the Croatian market with this medicine and revocation of the marketing authorisation.

Further information is accessible under the link below.

Information on the recall of two batches of Tyrez 2.5 mg film-coated tablets (bisoprolol)

28.02.2014

The company Alkaloid d.o.o., marketing authorisation holder for Tyrez 2.5 mg film-coated tablets (bisoprolol), has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision of the manufacturer, Alkaloid Int. d.o.o. on the recall of two batches of this medicinal product. Due to a quality defect discovered during further stability testing, the batches No 587770213 and 646340713 are being recalled from the market. The toxicological evaluation has confirmed no toxicological risk for patients. The medicinal product has been recalled due to preventive reasons at the level of wholesales, who are informed by the marketing authorisation holder about the recall.

There are other batches of Tyre2, 2.5 mg film-coated tablets currently available in Croatia and not affected by this quality defect and recall.

Information on the deadline prolongation for submission of medicines consumption in Croatia in 2013

28.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) is informing that the deadline for submission of medicines consumption data from 2013 has been prolonged to 14 March.

Workshop: “Regulatory framework in medicinal products distribution”

27.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb, a one day workshop “Regulatory framework in medicinal products distribution” intended to wholesales authorisation holders. Workshops will be held at HALMED’s premises, Ksaverska cesta 4. The exact date of the first workshop will be announced later, depending on the number of registered participants.
Detailed information is available under the link below.

CHMP News - February 2014

26.02.2014

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products has recommended for marketing authorisation authorisations ten new medicinal products, adopted recommendations in referral procedures for methysergide containing medicines and in referral procedures for Protelos/Osseor and has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic hepatitis C virus.

Further information is accessible under the link below.

HALMED participates in SCOPE Project

25.02.2014

The Agency for Medicinal Products and Medical Devices (HALMED) participates in the European Commission’s project entitled “Joint Action on Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)”. The project is being carried out with the aim to improve the health of European citizens by encouraging collaboration among Member States for effective operation of the pharmacovigilance system in the EU. The project started on the 1st November 2013 and is planned for three years.

Further information is availabele under the link below.

European Medicines Agency recommends restricting the use of methysergide-containing medicines

24.02.2014

The European Medicines Agency (EMA) has recommended restricting the use methysergide-containing medicines due to concerns that these medicines could cause fibrosis, a condition in which fibrous tissue accumulated in the body’s organs potentially damaging them. Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches ( a type of severe, recurring headache on the side of the head, usually around the eye) when standard medicines have failed.

Further information is available under the link below.

European Medicines Agency recommends further restrictions for use of Osseor and Protelos

24.02.2014

The European Medicines Agency (EMA) has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. These medicines should only be used in patients who cannot take other medicines for osteoporosis treatment. In addition, doctors should continue to regularly monitor the patients every 6 to 12 months and the Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled or angina. According to the aforementioned, patients with heart problems or peripheral arterial disease in disease history should not use this medicines.

Further information is accessible under the link below.

European Medicines Agency and US Food and Drug Administration continue strengthening collaboration in pharmacovigilance area

21.02.2014

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) continue strengthening collaboration in pharmacovigilance area by setting up a cluster of regular meetings which focus on medicines safety topics.

Further information is available under the link below.

Dear Healthcare Professional Letter on the introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa-2b)

20.02.2014

Merck Sharp & Dohme (MSD), 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 introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa -2b).

Detailed information and the Dear Healthcare Professional Letter are accessible below.

For Patients and Public

For Health Care Professionals

For Industry Representatives