News and Educations

Dear Healthcare Professional Letter on recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding

16.12.2014

Eli Lilly Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding.

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

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Visit of HALMED delegation to the Kosovo Medicines Agency (AKPPM)

11.12.2014

Upon invitation by the Kosovo Head of Agency, Mr Arianit Jakupi, a delegation of the Agency for Medicinal Products and Medical Devices (HALMED) led by the Head of Agency, Dr Viola Macolić Šarinić, MD, PhD, visited from 8 to 9 December 2014 the Kosovo Medicines Agency (AKPPM). HALMED and the AKPPM concluded a mutual collaboration agreement in 2013 in the field of the OMCL and regulatory affairs regarding medicines authorisation and pharmacovigilance.

The Croatian delegation was also received on 9 December 2014 by the Kosovo Minister of Health, Professor Ferid Agani for a brief discussion confirming that the Kosovo Medicines Agency would recognise all marketing authorisations issued by HALMED without repeating the assessment and thus speeding up and facilitating the granting of marketing authorisations for medicinal products of Croatian manufacturers in Kosovo. This provision is set out in the new ordinance on granting a marketing authorisation that is pending and is under the responsibility of the Kosovo Ministry of Health. This agreement paves the way for Croatian pharmaceutical manufacturers to place their medicinal products on the Kosovo market, as HALMED is being recognised as a safe and responsible partner in the regulatory environment of the region, ensuring efficacious, quality and safe medicines to all patients and users.

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Dear Healthcare Professional Letter on new contraindications and recommendations for minimising risks from cardiovascular events and severe bradycardia associated with the use of Procoralan and Corlentor (ivabradine)

10.12.2014

Servier Pharma d.o.o., the local marketing authorisation holder’s representative for Procoralan and Corlentor (ivabradine), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommendations for use of ivabradine to minimise the risk from cardiovascular events and severe bradycardia.

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

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Dear Healthcare Professional Letter on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride)

09.12.2014

Bracco International BV, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform health care professionals on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride).

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

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Notice on the occurrence of suspected falsified batches of MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion

08.12.2014

Via the Rapid Alert System from the German competent authority, the Agency for Medicinal Products and Medical Devices (HALMED) has received a notice on the suspected counterfeit batches of MabThera 100 mg concentrate for solution for infusion (batch: H0156B09, shelf-life: 05/2016) and MabThera 500 mg concentrate for solution for infusion (batch: H0721B04, shelf-life: 04/2016).

These batches reported as a suspected counterfeit have never been placed on the Croatian market.

More information is accessible under the link below.

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Notice on quality defect of the batch H55110 of Prevenar 13

08.12.2014

Pfizer Croatia d.o.o., the representative of the marketing authorisation holder in the Republic of Croatia for Prevenar 13 has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batch H55110 of this medicinal product. It is discovered that the package leaflet for Prevenar 13 in single dose vial (0.5 ml) is inserted in the packaging for Prevenar 13 in single dose pre-filled syringe (0.5 ml). These two package leaflets differ in the title and in the section “How Prevenar 13 appears and package content”. Both vaccines are already ready for use, but when administering the vaccine in single dose vial, the solution should be aspirated into the syringe.
HALMED agrees that the marketing authorisation holder’s representative distributes these batches with accompanying notes intended to wholesalers, healthcare professionals and patients as well as the correct package leaflet.

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Overview of the Workshop ”OTC medicines: the role of good classification practices in promoting medication safety and accessibility in Europe”

04.12.2014

An expert workshop “OTC medicines: the role of good classification in promoting medication safety and accessibility in Europe” organised by the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) was held from 20 to 21 November 2014 in Zagreb. Nearly 100 participants from 19 countries in Europe, representing national and European competent drug authorities, ministries of health, healthcare professionals, patients’ organisations, the pharmaceutical industry and pharmaceutical wholesalers involved in classification of medicines as regard their supply.

Welcome speeches were held by Susanne Keitel, PhD, the Director of EDQM, Viola Macolić Šarinić, MD, PhD, the Head of HALMED and chair of the EDQM’s Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO).

The workshop was aimed at providing extended knowledge to participants and to familiarise them with the work of the Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO), which annually issues recommendations to health authorities of European Pharmacopoeia member states for the classification of medicines and establishes good classification practices, and to collect feedback from the different stakeholders, including patient associations.

More information is accessible under the link below.

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Dear Healthcare Professional Letter on the case of progressive multifocal leukoencephalopathy in Tecfidera (dimethyl fumarate) treated patient with severe and prolonged lymphopenia

04.12.2014

In agreement with the agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), Medic Adria d.o.o. is sending a letter to healthcare professionals on the important safety information with regard the case of progressive multifocal leukoencephalopathy (PML) associated with the use of Tecfidera for the treatment of multiple sclerosis.
More information and the Dear Healthcare Professional Letter are accessible under the link below.

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No evidence that Fluad vaccine caused deaths in Italy - EMA Committee review reassures Member States over safety of flu vaccine

03.12.2014

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no evidence that Fluad, a flu vaccine manufactured by Novartis, has caused serious events including deaths in Italy. These reports led the Italian Medicines Agency (AIFA) to suspend the use of two batches of Fluad as a precautionary measure on 27 November 2014.

Fluad is authorised in the European Union (EU) in a number of Member States. For the current vaccination campaign in Italy, about 4 million doses of Fluad have been distributed. The vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain. Fluad is not on the Croatian market.

More information is accessible under the link below.

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Dear Healthcare Professional Letter on the risk of lack of efficacy due to incorrect reconstitution and administration of Eligard (leuprorelin acetate depot injection)

03.12.2014

In agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), Astellas d.o.o. has sent a letter to heathcare professionals on the risk of lack of efficacy due to incorrect reconstitution and administration process of Eligard (leuprorelin acetate depot injection).

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

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