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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22.10.2014
The workshop “The Role of Good Classification Practices in Promoting Medication Safety and Accessibility in Europe” will be organised by the Agency for Medicinal Products and Medical Devices (HALMED) and European Directorate for the Quality of Medicines and Healthcare (EDQM) from 20 to 21 November 2014 in Zagreb.
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20.10.2014
The 37th Annual Meeting of representatives of the National Centres participating in the WHO Programme for International drug Monitoring was held from 14-17 October 2014 in Tianjin, China. This meeting was jointly organised by the World Health Organisation (WHO), WHO’s collaborative centre for adverse reaction monitoring, Uppsala Monitoring Centre (UMC), Chinese Food and Drug Administration (CFDA). The Head of the Croatian Agency, Viola Macolić Šarinić, MD, PhD and her co-workers also participated at the meeting. The meeting was attended by some 200 representatives of National centres from 54 countries worldwide participating in the programme.
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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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20.10.2014
The Agency for Medicinal Products and Medical Devices (HALMED) released the text of Development Strategy for period 2014-2018. The text is available on HALMED's Internet pages in About Us section.
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20.10.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has included in its medicinal product database on its webpages, a new category “Medicinal product is placed on the market in Croatia”. Every medicinal product in this database, in this field, depending on its status on the market may be allocated values like Yes, No, Shortage, Permanent discontinuation in the supply chain or Temporary discontinuation in the supply chain. The database may be searched by using one of these criteria.
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