27.10.2014
The European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) recommended on its October 2014 meeting granting a marketing authorisation for six new medicines, gave recommendations for extension of indications for Xtandi and concluded the safety review for Iclusig (ponatinib) for medicines containing antibiotics colistin or colistimethate sodium.
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27.10.2014
GlaxoSmithKline, the marketing authorisation for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the potential incident of cracks of these medicine.
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24.10.2014
Berlin-Chemie Menarini Croatia d.o.o., the marketing authorisation holder for Ibustar for children 20 mg/ml oral suspension (ibuprofen), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batches 32004 and 41005 of this medicinal product due to a discovered quality defect.
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23.10.2014
The European Medicines Agency (EMA) announced today in a press release that it was ready to start assessment of Ebola vaccines and treatments as soon as data were made available.
Over last several months the Agency has established a system that provides the best possible scientific advice to companies working currently on development of potential vaccines and/or treatments for fighting the Ebola virus. The Agency has also established a form of rolling review that allows experts to continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process.
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22.10.2014
Following to the Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection, released on 8th October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the continuation of delivery of batches H58480 and H76658 of this medicine.
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20.10.2014
The Agency for Medicinal Products and Medical devices (HALMED) is publishing on its webpages Summaries of Risk Management Plans
The summary of risk management plan is information on risks of use of an individual medicinal product written in a simple and comprehensible manner and proved and verified from the relevant competent authority. The summary of risk management plan is intended to healthcare professionals and patients or their carers who want relevant and evidenced based information on the most important risks associated with use of a certain medicine.
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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.
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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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16.09.2014
Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.
Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.
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09.09.2014
Novartis Croatia d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals to warn them against off-label use of basiliximab (Simulect) in heart transplantation.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.
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