14.07.2014
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting.
Detailed information is accessible under the link below.
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11.07.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing all its clients that the applications Web offers and Croatian Pharmacopoeia will be temporary unavailable tomorrow, 12th July 2014, from 7 a.m. to 9 p.m. due to an upgrading of the IT system.
We thank you for your understanding.
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10.07.2014
Here you can find the list of medicinal products approved in the Republic of Croatia from 1 January to 30 June 2014 containing new active substances, i.e. substances newly approved in Croatia.
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03.07.2014
Pliva Croatia d.o.o., the marketing authorisation for Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel), has informed the Agency for Medicinal Products and Medical Devices (HALMED) abot the decision to recall the batch 0380313 of this medicinal product due to a quality defect. The quality defect was discovered during stability studies at 25°C/60%RH, after 12 months, where the obtained result was out of specification for the parameter Related substances.
There are sufficient quantities of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion batches not affected by this quality defect and recall and that are available on the Croatian market.
Detailed information is accessible under the link below.
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01.07.2014
The Agency for Medicinal Products and medical devices (HALMED) is informing hereby all its customers that due to technical difficulties some news in the section News were not visible and not sent in the HALMED Newsletter to recipients. The problem has been successfully solved and all posted news are again visible and will be sent via Newsletter
We thank you for your understanding.
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01.07.2014
The Agency for Medicinal Products and Medical Devices (HALMED), under Medicinal Products Act (Official Gazette, No 76/13) from 15 July 2014 starts allocating the Marketing Authorisation Number.
detailed information on the allocation procedure, lay out and characteristics of the Marketing Authorisation Number is accessible under th elink below.
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01.07.2014
CIS bio international and Marti Farm d.o.o. have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about important information associated with the use of Scintimun (besilesomab).
Summary
• Due to potential risk of human anti-mouse antibody forming (HAMA) that may lead to a type III hypersensitivity reaction, HAMA test should be carried out in all patients before use of Scintimun. The positive result is contraindicated for use of this medicine.
• Hypersensitive reactions may be in the whole range from mild allergic reactions to those life-threatening (including anaphylactic and anaphylactoid reactions).
• Due to acute hypotension risk, adequate therapeutic measures should be available in place in case the acute hypotension occurs as an individual reactions or associated with any clinical sign of the hypersensitivity reaction. The reanimation equipment should be available in the immediate proximity (i.e. ambulance, intensive care unit, etc.).
Detailed information is accessible under the link below.
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30.06.2014
The European Commission has introduced a common logo for online pharmacies in the European Union enabling patients to recognise authorised online pharmacies and thus avoid the danger of buying falsified medicinal products. The logo will appear on the websites of legally operating online pharmacies in the EU confirming their authenticity and safety, i.e. confirming that the medicines they offer are of approved quality and are safe for use. The logo will lead the Croatian citizens to the website of the Agency for Medicinal Products and Medical Devices (HALMED), where all legally operating online pharmacies established in the Republic of Croatia will be listed. If the pharmacy is not listed therein, citizens are advised not to buy the medicines this way.
Detailed information is accessible under the link below.
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30.06.2014
The Committee for Human Medicinal Products (CHMP) has recommended granting a marketing authorisation for six new medicines, adopted a positive opinion for medicine Vantobra and recommended extensions of indications for Avastin, Eliquis, Enbrel, Eylea, Isentress, Kalydeco and Stivarga.
Detailed information is accessible under the link below.
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26.06.2014
Pfizer Croatia d.o.o., the marketing authorisation holder for Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etopodide), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of the batch HW52C of this medicine. The recall is due to an error in the product name in the package leaflet and labelling.
Detailed information is accessible under the link below.
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