Newly approved medicinal products
19.03.2014
The list of newly approved medicinal products for the period between 1st February 2014 and 28th February 2014 is available in the continuation of this notice.
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News and Educations
Educational course “Distribution of medical devices”
17.03.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.
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Quality defect report to Soliris 300 mg concentrate for solution for infusion
12.03.2014
Alexion Pharma International has informed the Agency for Medicinal Products and Medical Devices (HALMED) of the quality defect of two batches of Soliris 300 mg concentrate for solution for infusion (eculizumab) of the marketing authorisation holder Alexion Europe SAS-France. The report refers to the batch No 00009 and No 00016, where in the Republic of Croatia only the batch No 00016 is distributed.
Detailed information is accessible under the link below.
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On-going works on HALMED’s infrastructure
12.03.2014
Due to on-going works on the Agency for Medicinal Products and Medical Devices IT infrastructure on Wednesday, 12 March 2014, from 17.00 to 22.00 a temporary unavailability of the HALMED staff via phones and e-mail as well as the HALMED on-line application is possible.
We thank you for your understanding.
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Dear Healthcare Professionals Letter on new restrictions of the indication and recommendations for monitoring of Osseor/Protelos (strontium ranelate) use
11.03.2014
Servier Pharma d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) sent out a letter on new restrictions in the indication and recommendations for monitoring of Osseor/Protelos use of EMA’s review of risks and benefits of strontium ranelate. Available data do not demonstrate an increased cardiovascular risk in patients without contraindications for use included in April 2013.
Detailed information and Dear Healthcare Professional Letter are available under the link below.
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PRAC News –March 2014
07.03.2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) adopted at its meeting held in March 2014, new recommendations regarding the safe use of medicines throughout the European Union (EU). The PRAC recommended restrictions in use of domperidone, after re-examination, the PRAC recommended restrictions in use of diacerein and the incorporation of new safety information in medicines information of all zolpidem containing medicinal products.
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Notice to users on the possible temporary unavailability of the HALMED staff via office mobile phones and switchboard
06.03.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing its clients that on the 7 Friday 2014, from 8 to 12 a.m., there will be a temporary unavailability of the HALMED staff via official mobile phones and switchboard due to a change of mobile phone provider.
We thank you for your understanding.
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Information on the recall of Thymoglobuline 25 mg powder for solution for infusion
05.03.2014
The company sanofi-aventis Croatia d.o.o., the marketing authorisation holder for Thymoglobuline 25 mg powder for solution for infusion has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision to recall the batches of the above mentioned medicinal product, because the product’s manufacturer found that it fell out of specification during ongoing stability study.
The recall has been initiated for the following batches on the Croatian market: C1272H05, C1272H19, C1282H11, C1282H42, C1306H03 and C1306H23. The recall is preventive and is performed to the wholesalers’ level. The marketing authorisation holder will inform them about the recall. The recall of the above mentioned batches does not affect the regular supply chain with Thymoglobuline 25 mg powder for solution for injection as other batches not affected by this problem are available on the market.
Further information is accessible under the link below.
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International Rare Diseases Day – 12 new orphan medicines authorised in the EU over the past year
03.03.2014
Over the past year, a total of twelve medicines for the treatment of rare diseases were recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP). The marketing authorisations of these medicines became valid in Croatia from the date of the accession to the EU, thus providing affordability of these medicines to Croatian patients. You may read more about the newly authorised orphan medicinal products on the European Medicines Agency webpages or here.
The Agency for Medicinal Products and Medical Devices (HALMED) joined this year the Croatian Association for Rare Diseases in manifesting this day. Within this manifestation, the HALMED representatives held workshops on the importance of adverse reactions reporting. A lecture was held within the 3rd Croatian Symposium and National Conference on the Rare Diseases on the HALMED’s role in medicines affordability after the accession to the EU.
Further information is accessible under the link below.
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Information about the interruption in manufacturing and supply chain with Norcuron 4 mg powder for solution for injection or infusion (vecuronium bromide)
03.03.2014
The marketing authorisation holder for Norcuron 4 mg powder for solution for injection or infusion (vecuronium bromide), Merck Sharp & Dohme d.o.o., has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the interruption in manufacturing and supply chain of the Croatian market with this medicine and revocation of the marketing authorisation.
Further information is accessible under the link below.
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