19.11.2015
Following to the Notice on the beginning of use of electronic application forms (eAFs)for granting a marketing authorisation, renewal or variation, we would like to offer further information to marketing authorisation holders.
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18.11.2015
The Agency for Medicinal Products and Medical Devices (HALMED) actively participates in rational use of antibiotics in Croatia and continuously promotes their rational and correct use. Viola Macolić Šarinić, MD, PhD, Assist. Prof., the Head of HALMED, called upon on this occasion on all doctors and patients to prescribe antibiotics and use them responsively and consciously, emphasising: “Even though certain results have been achieved in Croatia in the field of rationalisation, this is our ultimate goal that we have to continue to work on”.
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17.11.2015
On the 16th November 2015 Professor Guido Rasi took over as Executive Director of the European Medicines Agency (EMA).
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16.11.2015
Fresenius Kabi d.o.o., the marketing authorisation holder for Cefepime Kabi powder for solution for injection or infusion (cefepime) à 1 and 2 g, has notified the Agency for Medicinal Products and Medical devices (HALMED) of an expected shortage of these medicinal products on the Croatian market.
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16.11.2015
PharmaSwiss d.o.o., the marketing authorisation holder for Megostat 40 mg/ml oral suspension (megestrol), has notified the Agency for Medicinal Products and Medical Devices (HALMED) of an expected shortage with this medicine on the Croatian market.
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16.11.2015
The Agency for Medicinal Products and Medical Devices (HALMED) as a competent authority for monitoring the supply of the Croatian market with medicines, is informing all wholesale license holders (wholesalers) that it is notified by the Croatian Institute for Public Health (CIPH) of the need for procurement of 10.000 doses of Diphtheria, tetanus and pertussis (acellular) vaccine.
HALMED is therefore inviting wholesalers to, in compliance with measures for protection of human health, in a shortest period, gather information on the availability of this vaccine quantity in other countries and submit them to HALMED.
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12.11.2015
New visual identity, clearer and more intuitive user interface, approach adjusted to various interest groups, improved functionalities and better organisation of an even greater quantity of information.
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11.11.2015
We would like to inform you that redesigned webpages of the Agency for Medicinal Products and Medical Devices (HALMED) will be launched tomorrow afternoon.
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11.11.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform of the recall of the batch 242562 of Nitronal solution for infusion 50 ml (1 mg/ml) (glyceryl trinitrate) of the manufacturer Pohl Boskamp, Germany, due to a suspected quality defect.
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09.11.2015
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