Newly approved medicinal products
16.01.2014
The list of newly approved medicinal products for the period between 1st December 2013 and 31st December 2013 is available in the continuation of this notice.
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News and Educations
The Agency’s Price List and Web Offers application are available again
15.01.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing all its clients that the modified and amended Price List that came into effect on the 14 January 2014 is accessible on the HALMED webpages. Also, after a short interruption due to harmonisation with modifications and amendments of the Price List, the Web Offers application is available for creating offers for procedures initiated by applicants, that serve for their payment execution.
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Dear Healthcare Professional Letter on the new information on dosing of ondansetron (Zofran) for intravenous use due to the association with QT prolongation
14.01.2014
GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter to healthcare professionals on the new information related to dosing of intravenous ondansetron used to prevent chemotherapy-induced nausea and vomiting (CINV). This includes new recommendations for repeated dosing and application in elderly patients.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.
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Proactive pharmacovigilance and risk management in the period of individualised therapy
14.01.2014
The International Society of Pharmacovigilance (ISoP) and Agency for Medicinal Products and Medical Devices (HALMED) are organising a workshop entitled “Proactive pharmacovigilance and risk management in the period of individuslised therapy” that will be held on 3 and 4 April 2014 in Zagreb.
The workshop is for representatives of competent authorities, pharmaceutical industry and academia.
More information is available under the link below.
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Information about a temporary unavailability of the Agency’s Price List and Web Offers application
14.01.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing all its clients that the price list for its services with modifications and amendments, coming into effect on the 14 January 2014, will be made publicly available today on the HALMED webpages. Due to harmonisation with changes in the Price List, the Web Offers application will be temporary unavailable. Users will be promptly informed about the application reactivation and availability of the Price List on the HALMED webpages.
We thank you for your understanding.
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PRAC recommends suspending use of Protelos and Osseor (strontium ranelate)
13.01.2014
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos and Osseor should no longer be used to treat osteoporosis.
Detailed information is available under the link below.
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Dear Healthcare Professional Letter on the need for carrying out hepatitis B screening in all patients before treatment with Arzerra (ofatumumab)
13.01.2014
GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter with new recommendations related to the screening of patients for hepatitis B antigen before the ofatumumab treatment.
Detailed information and the Dear Healthcare professional letter is accessible under the link below.
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List of approved medicinal products with new active substances
10.01.2014
Here you can find the list of medicinal products approved in the Republic of Croatia from 1 July to 31 December 2013 containing new active substances, i.e. substances newly approved in Croatia.
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Launch of the new on-line Croatian Pharmacopoeia Edition 3.0
10.01.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has published a new on-line edition of the Croatian Pharmacopoeia 3.0. The new edition is based on the eight edition of the European Pharmacopoeia, published on the 15 July and coming into effect on the 1st January 2014.
The new edition of the Croatian Pharmacopoeia is a follow up of the previous one 2.0 and includes all new, corrected and revised texts with commentaries on the news published in Pharmeuropa.
Detailed information is available under the link below.
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Dear Healthcare Professional Letter on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF)
08.01.2014
GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products (HALMED), has sent a letter to healthcare professionals on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF).
Detailed information and the Dear Healthcare Professional Letter are available under the link below.
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