Newly approved medicinal products
17.10.2014
The list of newly approved medicinal products for the period between 1st September 2014 and 30th September 2014 is available in the continuation of this notice.
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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.
More information is accessible under the link below.
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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.
More information is accessible under the link below.
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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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Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection
08.10.2014
Pfizer Croatia d.o.o., the marketing authorisation’s holder representative in the Republic of Croatia for Enbrel 25 mg powder and solvent for solution for injection, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batches H58480 and H76658 of this medicine.
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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CMDh News – September 2014
07.10.2014
The Co-ordination Group for Mutual Recognition and Decentralised Procedure for human medicines (CMDh) discussed at its meeting in September 2014 about the implementation of Commission’s Decisions after referral procedures pursuant to Article 30 of Directive 2001/83/EC of the European Parliament and Council for medicines, for which Commission’s Decision was adopted in August 2014.
Detailed information is accessible under the link below.
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Recall of the batch AIIM/1P of Torisel with corresponding solvent batch AHZW/99
07.10.2014
Pfizer Croatia d.o.o., the Croatian representative of the marketing authorisation holder for Torisel has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch AIIM/1P of this medicine with corresponding solvent batch AHZW/pp from the market due to a quality defect.
More information is accessible under the link below.
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