News and Educations

PRAC News – October 2014

14.10.2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate in women and girls, concluded that there is no evidence that testosterone-containing medicines increase the cardiovascular risk in patients with hypogonadism and recommended further measures to minimise risk of blood vessel blockage with ponatinib at its October 2014 meeting.

More information is accessible under the link below.

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PRAC recommends strengthening the restrictions on the use of valproate in women and girls

14.10.2014

The PRAC has recommended strengthening the restrictions on the use due to risks of congenital malformations and development problems in children exposed to valproate during pregnancy. The PRAC has recommended that valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.

Valproate has been used to treat epilepsy and bipolar disorder. Some valproate medicines are also authorised in some EU Member States, Croatia included, to prevent migraine headaches.

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EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)

14.10.2014

The European Medicines Agency has completed a review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the EMA has recommended that further measures should be put in place to minimise the risk of liver toxicity. Valdoxan and Thymanax are two identical medicines used to treat major depression in adults.

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Instructions for reporting variations in the documentation for medicinal products resulting from referral procedures for levonorgestrel-containing medicines for emergency contraception

10.10.2014

The European Commission adopted on 30 September 2014 Decision on marketing authorisations for human medicinal products containing levonorgestrel, pursuant to Article 31 of Directive 2001/83/EC of the European Parliament and Council (Procedure number EMEA/H/A-31/1391). Detailed information on this decision is available on the Europena Commission’s webpages.

HALMED calls upon all marketing authorisation holders in the Republic of Croatia for medicinal products belonging to the pharmaco-therapeutic group of emergency contraceptives and containing levonorgestrel (listed in Annex I of Commission’s Decision) to submit a variation application within 8 days from the release of this information.

Detailed information is available in the Medicines/Instructions for reporting varaiations in the documentation resulting from referral procedures/Levonorgestrel-containing medicines for urgent contraception section or under the link below.

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HALMED participates in the WEB-RADR project

09.10.2014

The Agency for Medicinal Products and Medical Devices (HALMED) participates in the European Commission’s project Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions). It is a joint private public partnership project (IMI project) that aims at developing the easiest and most accessible reporting system for suspected adverse reactions to medicines by using new channels and social networks. In this project, in addition to HALMED, the European Medicines Agency (EMA) and the Medicines and Healthcare Regulatory Agency (MHRA) also actively participate in the project. HALMED has received compliments for its contribution by the American Food and Drug Administration (FDA) and Croatia will alongside the FDA voluntarily contribute to the project to facilitate the reporting of suspected adverse reactions by using mobile apps.
Detailed information is accessible under the link below.

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Recall of CooperVision Proclear toric contact lenses

08.10.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received from a medical device manufacturer CooperVision, England, a notification on the recall of the medical device Proclear toric contact lenses.Taking account that there is no risk for users, the recall of the batches 100375500080080717, 104235500040220516 and 104275000160220117 is being carried out at the retail level.

Detailed information is accessible under the link below.

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