Newly approved medicinal products
12.04.2013
Here you can find a list of newly approved medicinal products between 1st February 2013 and 28th February 2013.
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News and Educations
Newly approved medicinal products
10.04.2013
Here you can find a list of newly approved medicinal products between 1st January 2013 and 31st January 2013.
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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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Information about the temporary suspension of sales and administration of the batch 2821211 of the medicinal product Gemcitabin Pliva 200, powder for solution for infusion
29.03.2013
The company Pliva Hrvatska d.o.o., the marketing authorisation holder for the medicinal product Gemcitabin 200, powder for solution for infusion, has, upon the request of the Agency for Medicinal Products and Medical Devices (HALMED) initiated a temporary suspension of sales and administration of the product’s batch 2821211.
The procedure of temporary suspension of sales and administration of the above mentioned products’s batch has been initiated after HALMED received a quality defect report from a health care professional on 29 March, 2013, who had discovered a glass particle of 5 mm in the product vial.
The existing stock of the batch remain on the market. However, they should not be dispensed or administered. HALMED has requested sampling from the Ministry of Health and samples will be submitted to HALMED for testing. The suspension of the administration of the aforementioned batch will be in effect as long as quality control results have not been gathered as well as other safety reviews by HALMED have not been completed, about which HALMED will inform the public.
The marketing authorisation holder has informed wholesalers and health care professionals about the suspension of sales and administration of the aforementioned product batch.
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Opening hours of the Registry Office, on 29 March 2013
25.03.2013
We inform all our customers that the opening hours of the Registry Office of the Agency for Medicinal Products and Medical Devices on Friday, 29 March 2013, will be from 8.00 a.m. to 12 a.m.
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Information about the stopping of the medicinal product Vermox oral suspension 100 mg/5ml (mebendazol) production
22.03.2013
KRKA-FARMA d.o.o., the marketing authorisation holder for the medicinal product Vermox suspension 100 mg/5 ml (mebendazole) has informed the Agency for Medicinal Products and Medical Devices about the production stopping of the product.
There is no other authorised medicinal product for the same indication in Croatia. There is a possibility of a substitution therapy import under the legal exemption scheme for patients who need treatment with this product.
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Continued information about the shortage of the medicinal product Detrunorm XR 30 mg modified release capsules (propiverine)
21.03.2013
Merck, Sharp & Dohme d.o.o., the marketing authorisation holder for the medicinal product Detrunorm XR 30 mg modified release capsules (propiverine), hasd informed the Agency for Medicinal Products and Medical Devices about the shortage of this product on the Croatian market. HALMED reported about this shortage on 31 October 2013 on its webpages. The shortage is due to administrative reasons.
The normalisation of the supply chain with this medicinal product is expected in the third quarter of 2013. The medicinal product Detrunorm 15 mg coated tablets of the same manufacturer not affected by this shortage is available on the Croatian market.
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The conference “EU28: science, medicines, health – a regulatory system fit for the future” is now open for registration
20.03.2013
The international conference “EU28: science, medicines, health – a regulatory system fit for the future”, organised by the European Medicines Agency, EMA) and the Croatian Agency for Medicinal Products and Medical Devices (HALMED) will be held on 6-7 May 2013 in the Hotel Palace in Dubrovnik.
Further information you may find in the continuation of this information.
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Volontary recall of the medical device OneTouch Verio®Pro – glycaemic self-management system intended for home and ambulatory care, manufactured by LifeScanEurope
19.03.2013
The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro – glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope – Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
Hereby we inform all users to stop using the product OneTouch®Pro – glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro – glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.
Further information is available in the continuation of this information.
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Adverse Reactions Report for 2012
15.03.2013
On 15 March 2013, the Agency for Medicinal Products and Medical Devices (HALMED) made available on its internet pages the Adverse Reactions Report for 2012.
You may view the Summary of the Report in the continuation of this information.
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