Pharmacovigilance

Information about the temporary distribution of Partusisten 5 mg tablets

01.10.2013

Boehringer Ingelheim Zagreb d.o.o. , the marketing authorisation holder for Partusisten 5 mg tablets (fenoterol) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to temporary interrupt the distribution of the medicinal product as a precaution measure until the outcome of the arbitration procedure in the course in the EU for short-acting beta agonists in obstetric indications, due to findings that indicate an insufficient efficacy of oral forms of these medicines.

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Report to the European Commission about the internal audit of the pharmacovigilance system in the Agency for Medicinal Products and Medical Devices

30.09.2013

Given that national competent authorities and marketing authorisation holders are required to carry out internal audits of their pharmacovigilance systems in accordance with the guideline on Good Pharmacovigilance Practice (GVP) Module IV – Pharmacovigilance audits, the Agency for Medicinal Products and Medical Devices (HALMED) submitted on 17 September 2013 a report to the European Commission about the internal audit of its pharmacovigilance system for the period between 1 July – 16 September 2013.
You may find the report along with additional information in the continuation of this notice.

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News from the PRAC – September 2013

17.09.2013

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) at its meeting held in September 2013 gave new recommendations for EU countries.
The recommendations include restrictions to the use of short-acting beta-agonists in obstetric indications, temporary suspension of the marketing authorisation and reformulation of Numeta G16%E, as well as risk minimisation measures for Numeta G16%E.
Besides, the PRAC has initiated a new safety assessment for bromocriptine-containing medicinal products. The PRAC will assess whether the benefits of these medicines outweigh the risk of potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects.

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Start of a new HALMED’s campaign on promoting the importance of package leaflet reading and reporting of ADRs

11.09.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has started a public education campaign aimed at promoting the importance of package leaflet reading and ADR reporting among patients and end consumers. The aim of the campaign is to inform citizens that, alongside the information provided by a qualified healthcare professional, additional information may be obtained through package leaflet reading and to motivate them to get actively involved in the medication and monitoring of safe use of medicines by reporting ADRs. This approach will further contribute to the improvement of the safe use of medicines and more efficient health care for patients and overall public health.
The campaign will intensively be carried out at the national level from the beginning of September to the end of October this year through billboard, press ads, radio spots, on-line banners, posters in doctors’ waiting rooms and information leaflets on ADRs reporting that will be available in pharmacies throughout the country.

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Dear Health Care professional letter about the importance of careful use of medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban)

05.09.2013

The marketing authorisation holders for medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) have, in collaboration with the European Meidines Agency (EMA) and Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals with the aim to remind them about the careful use of these medicines.
Clinical trials and the post-marketing experience have demonstrated that the occurrence of major bleeding, including the events that led to death are not limited only to vitamin K antagonists and low-molecular weight heparins, but represent important risks associated with the use of these new anticoagulants. Furthermore, spontaneous reporting of adverse reactions to these medicines indicate that prescribers are not well informed about these medicines with regard to bleeding risk management.

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Dear Healthcare Professional Letter on the association of clopidogrel (medicinal products Plavix 75 mg and 300 mg film coated tablets and Duoplavin 75 mg/75 mg and 75/100 mg film-coated tablets) with acquired haemophilia

26.08.2013

sanofi-aventis Croatia d.o.o., the representative of the marketing authorisation holder Sanofi Pharma Bristol-Myers Squibb SNC in the Republic of Croatia for medicinal products Plavix 75 mg and 300 mg film-coated tablets and Duoplavin 75mg/75mg and 75 mg/100 mg film coated tablets, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about an important information related to the use of clopidogrel.
The letter informs healthcare professionals about the new and special warnings and cautionary measures related to the use of those medicines due to their association with the acquired haemophilia.

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Dear Healthcare Professionals letter about the restriction of the use of the medicinal product Trobalt (retigabine) due to the risk of discolouration of eye tissues including retina, skin, lips and/or fingernails

19.08.2013

Glaxo Smith Kline d.o.o., the marketing authorisation holder for the medicinal product Trobalt (retigabine) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) issued a letter to healthcare professionals about the restriction of indications for the medicinal product due to a risk of discolouration of eye tissues, including retina, skin, lips and/or nailfingers.

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News from PRAC – June 2013

17.06.2013

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) made four recommendations for the EU member states on four safety referrals at its June 2013 meeting.

Recommendations include further: restriction of the use of codeine for pain relief in children, the same precautions for diclofenac as for selective cox-2 inhibitors, the suspension of infusion solutions containing hydroxyethyl starch, the restriction of use of flupirtine-containing medicines.

Since these four PRAC recommendations concern medicinal products approved through national procedure, they will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

Detailed information can be found in the continuation of this notice.

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