Medicinal Products

Information on temporary recall of Cefexin 100 mg/5 ml powder for oral suspension (cefiximum)

30.04.2014

Pliva Croatia d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is available under the link below.

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Information on temporary recall of Cefiksim Jadran 100 mg/5 ml powder for oral suspension (cefiximum)

30.04.2014

Jadran Galenski laboratoj d.d. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine.
Further information is accessible under the link below.

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Dear Healthcare Professional Letter on eventual need for earlier re-vaccination with conjugated vaccines in individuals vaccinated with Mencevax ACWY Vaccine, who are highly at risk of exposure to serogroups A, W-135 and Y

25.04.2014

GlaxoSmithKline d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the available persistence data of Mencevax ACWY Vaccine.
Detailed information and the dear Healthcare professional Letter is assessible under th elink below.

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Dear Healthcare Professional Letter on falsified medicines labelled as Herceptin 150 mg, powder for concentrate for solution for infusion (trastuzumab)

24.04.2014

Following to the Note to healthcare professionals about falsified Herceptin in the EU and Information on counterfeited Herceptin, Alimta and Remicade on the EU market, Roche d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals, The letter contains the updated information on falsified medicines labelled as Herceptin 150 mg powder for concentrate for solution for infusion (trastuzumab) in the EU as well as instructions for visual inspection of vials before preparation and administration of medicines.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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Dear Healthcare Professional letter on the new list of devices compatible for blood glucose level determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)

09.04.2014

The company Agmar d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new list of devices compatible for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin). The letter contains the new list of devices for blood glucose determination permitted to be used in those patients. The letter follows up to the previous letters addressed to doctors, that HALMED reported on its webpages in June 2008, July 2010 and August 2011.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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CHMP and CMDh news – March 2014

24.03.2014

The Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human (CMDh) has endorsed recommendations to restrict the use of diacerein-containing medicines. The Committee for Human Medicinal Products (CHMP) has recommended granting a marketing authorisation for nine new medicines, recommended extensions of indications for Pegasys, Tresiba and Victoza and concluded its review of the safety of propylene glycol in intravenous formulations. Also, the CHMP adopted recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza in winter 2014/2015. Further information is accessible under the link below.

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Dear Healthcare Professionals Letter on new restrictions of the indication and recommendations for monitoring of Osseor/Protelos (strontium ranelate) use

11.03.2014

Servier Pharma d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) sent out a letter on new restrictions in the indication and recommendations for monitoring of Osseor/Protelos use of EMA’s review of risks and benefits of strontium ranelate. Available data do not demonstrate an increased cardiovascular risk in patients without contraindications for use included in April 2013.

Detailed information and Dear Healthcare Professional Letter are available under the link below.

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PRAC News –March 2014

07.03.2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) adopted at its meeting held in March 2014, new recommendations regarding the safe use of medicines throughout the European Union (EU). The PRAC recommended restrictions in use of domperidone, after re-examination, the PRAC recommended restrictions in use of diacerein and the incorporation of new safety information in medicines information of all zolpidem containing medicinal products.

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International Rare Diseases Day – 12 new orphan medicines authorised in the EU over the past year

03.03.2014

Over the past year, a total of twelve medicines for the treatment of rare diseases were recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP). The marketing authorisations of these medicines became valid in Croatia from the date of the accession to the EU, thus providing affordability of these medicines to Croatian patients. You may read more about the newly authorised orphan medicinal products on the European Medicines Agency webpages or here.

The Agency for Medicinal Products and Medical Devices (HALMED) joined this year the Croatian Association for Rare Diseases in manifesting this day. Within this manifestation, the HALMED representatives held workshops on the importance of adverse reactions reporting. A lecture was held within the 3rd Croatian Symposium and National Conference on the Rare Diseases on the HALMED’s role in medicines affordability after the accession to the EU.

Further information is accessible under the link below.

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CHMP News - February 2014

26.02.2014

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products has recommended for marketing authorisation authorisations ten new medicinal products, adopted recommendations in referral procedures for methysergide containing medicines and in referral procedures for Protelos/Osseor and has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic hepatitis C virus.

Further information is accessible under the link below.

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