25.09.2015
At its September 2015 meeting, the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) recommended 19 new medicines for marketing authorisation. Also the CHMP recommended extensions of indication for six medicines.
Further information is accessible under the link below.
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25.09.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has recommended a temporary suspension of implantation of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has been discontinued in the Republic of Croatia. The suspension has been due to precautions after an unannounced inspection at the manufacturing site in Brasil discovered a impurity with particles on the surface of certain products of this manufacturer. According to the currently available safety data there are no indications that this issue could have a harmful effect on the health of patients with these implants.
Therefore, individuals with these implants are for now advised not to take any further steps than ordinary ones and regular controls according to doctor’s recommendations. In the case of concern patients should speak to their doctor who implanted the product.
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22.09.2015
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17.09.2015
The list of newly approved medicinal products for the period between 1st August 2015 and 31st August 2015 is available in the continuation of this notice.
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11.09.2015
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways. The PRAC aims to review the available data on the benefits and risks of these medicines and issue an opinion on their marketing authorisations across the European Union.
further information is accessible under the link below.
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11.09.2015
The European Medicines Agency (EMA) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways such as sinusitis (sinus infection) and tonsillitis (inflammation of the tonsils caused by an infection).
Further information is accessible under the link below.
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10.09.2015
The emergency contraception for preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. There are two oral emergency contraceptives without prescription currently authorised in Croatia. In order to ensure its correct and safe use, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to inform healthcare providers and users with information related to the use of these medicines.
Further information is accessible under the link below.
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10.09.2015
Ely Lilly d.o.o. Croatia, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is informing health care professionals on the new information on safe use of insulin lispro, the insulin analogue that is taken at meal times, available in the strength of 200 Units/ml (Humalog 200 Units/ml KwikPen) to treat the diabetes in adults.
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04.09.2015
The Republic of Croatia signed on 3 September 2015 the MEDICRIME Convention that for the first time at the international level defines the counterfeiting of medicinal products and medical devices, as well as their manufacturing and placing on the market without marketing authorisation or compliance with safety requirements as a pharmaceutical crime.
Further information is accessible under the link below.
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04.09.2015
Astellas, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) is informing healthcare professionals on the new recommendations for use of mirabegron (Betmiga) due to a risk of increased blood pressure.
Further information and the Dear Healthcare Professional Letter is accessible under the link below.
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