21.04.2009
The Agency for Medicinal Products and Medical Devices sent a letter to healthcare professionals with important safety information on methotrexate dosage for oral use when indicated for treatment of psoriasis and rheumatoid arthritis.
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18.04.2009
The Act on amendments to the Medicinal Products Act (Official Gazette No. 45/09.) came into effect on 18 April 2009.
The Act was published in the Official Gazette No. 45/09, as well as on the Internet pages of the Agency under the Legislation section.
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10.04.2009
Medic d.o.o., representative of the manufacturer Physio–Control Inc., USA, a Medtronic Group member, notified the Agency for Medicinal Products and Medical Devices of a defective printed board of a LIFEPAK 12 defibrillator/monitor component. This defect may cause a short circuit on the component, which may result in no therapy delivery or in delivery of inadequate defibrillation waveforms. There have been no reported adverse events due to this defect.
The representative has notified all users and organised the replacement of the incorrect printed boards with new ones.
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28.03.2009
The Agency for Medicinal Products and Medical Devices has withdrawn a batch of the Augmentin injection 1.2 g packaging with 5 bottles per box, batch no. 392761, of the marketing authorisation holder GlaxoSmithKline d.o.o., Zagreb, due to suspected quality defect.
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25.03.2009
In collaboration with the Agency for Medicinal Products and Medical Devices, on 25 March 2009, Bayer d.o.o. sent a letter to gynecology and dermatology specialists regarding the changes in the information on use of Yasmin (drosperinonum, ethinylestradiolum).
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23.03.2009
Having verified the adequate quality of this medicine, the Agency for Medicinal Products and Medical Devices approved the future use and marketing of the batch no. 1388 of Cordarone 150mg/3 ml injection, of the marketing authorisation holder Sanofi-Aventis Croatia d.o.o., which had been withdrawn for preventive reasons.
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17.03.2009
An additional information concerning the Sprint Fidelis electrodes was submitted to the Agency for Medicinal Products and Medical Devices by MEDIC d.o.o., representative of the manufacturer Medtronic. The information is linked to the prior withdrawal of the Sprint Fidelis electrodes in 2007.
The representative undertook to provide all users of the Sprint Fidelis electrodes with additional information within the shortest time possible.
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06.03.2009
The representative of the manufacturer Abbott Laboratories of USA, Abbott Laboratories d.o.o. notified the Agency for Medicinal Products and Medical Devices about the withdrawal of certain series of the Architect reaction vials. When using the specified series of the Architect reaction vials, a discharge of static electricity can occur.
The representative notified all users not to use the reaction vials carrying specified serial numbers and initiated the procedure for withdrawal of the product from the market.
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03.03.2009
In cooperation with the Agency for Medicinal Products and Medical Devices, Shering Plough d.o.o. sent a letter to physicians concerning the early termination of the LIBERATE clinical study due to a significant increase in risk of the breast cancer relapse in the group of study subjects taking the active substance tibolone in comparison with the group taking the placebo.
This clinical study has not been implemented in the Republic of Croatia.
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