Medicinal Products

Notice on the reported suspected adverse reactions to the Tetanus Vaccine, Institute of Immunology d.d. in Bosnia & Herzegovina

31.12.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has been notified by the Agency for Medicinal Products and Medical Devices of Bosina & Herzegovina (ALMBiH) about five reported suspected adverse reactions after the use of the Tetanus Vaccine (adsorbed), Institute of Immunology, batch 78/3 with the expiry date by August 2015. The tetanus vaccine is indicated for stimulating the active immunity against tetanus.

The Agency for Medicinal Products and Medical Devices B&H has concluded that the benefits/risks ratio for this vaccine remains positive. According to HALMED’s data, the Tetanus Vaccine manufactured by Institute of Immunology d.d., including this batch is not on the Croatian market.

More information is accessible under the link below.

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HALMED celebrates 40 years of spontaneous adverse reaction reporting in Croatia

24.12.2014

The Republic of Croatia celebrates this year forty years of spontaneous suspected adverse reaction reporting. On this occasion that is important for monitoring the safe use of medicines, the Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages a number of informative texts posted in the occasional section “40 years of spontaneous ADR reporting in Croatia” to make users and patients more familiar with the importance and procedures of suspected adverse reaction reporting as well as with the system of monitoring the safe use of medicines in Croatia.

The new section is available in the Pharmacovigilance/40 years of spontaneous reporting in Croatia section of the HALMED's webpages. More information is accessible under the link below.

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Notice on reintroducing the batch of Glucose 10% Viaflo solution for infusion on the market

17.12.2014

Following to the Notice on temporary disruption in delivery and use of the one batch of Glucose 10% Viaflo solution for infusion (glucose hydrate) of the marketing authorisation holder, Agmar d.o.o., published on 31 October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the reintroducing of the batch 14C17E3M of this medicine on the Croatian market.

More information is accessible under the link below.

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Dear Healthcare Professional Letter on the risk of abnormal pregnancy outcomes associated with the use of valproate (Depakine Chrono)

16.12.2014

Sanofi-aventis Croatia d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the risk of abnormal pregnancy outcomes associated with the valproate use (sodium valproate, valproic acid, fixed combination sodium valproate/valproic acid and valpromid are concerned), upon completion of the review of the available data in the entire Europe.

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

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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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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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