The international conference on medicinal products regulation “EU28:science, medicines, health – a regulatory system fit for the future” started today in Dubrovnik
06.05.2013.
The two-days international conference "EU28: science, medicines, health – a regulatory system fit for the future” was solemnly opened today. This conference has been jointly organised by the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED), under the auspices of the President of the Republic of Croatia, Professor Ivo Josipović and the Ministry of Health of the Republic of Croatia.
The conference has been supported by the IPA programme of the European Commission (Instrument for Pre-Accession Assistance programme), supporting, among others, the participation of candidate and potential candidate countries in the activities of European Institutions.
The conference was attended by about 250 participants – representatives from the civil service, public sector and pharmaceutical industry from EU Member States, Croatia, Albania, Bosnia & Herzegovina, Montenegro, Macedonia, Serbia and Kosovo under unscr 1244/99.
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Continued information about the recall of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion
29.03.2013.
The company PharmaSwiss d.o.o., the marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml solution for infusion, upon request of the Agency for Medicinal Products and Medical Devices is recalling the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion, due to a discovered quality defect.
The decision about the recall is based on the test results obtained by HALMED of the batch 2A74306, according to the announcement posted on 9 January, 2013.
All stocks of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion were, from 9 January 2013, according to the announcement on HALMED’s webpages, marked and recalled from stocks of hospital pharmacies and a ban on dispension of the batch to patients was in effect.
There are sufficient batches of the medicinal product Perfalgan 10 mg/ml on stock in Croatia, that are not affected by the suspected quality defect and recall from the market.
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