Medicinal Products

Dear Healthcare Professional Letter on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib)

13.10.2015

Pfizer Croatia d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) would like to inform healthcare professionals on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib).

Further information and the Dear Healthcare Professional Letter is accessible under the link bellow.

PRAC News – October 2015

12.10.2015

During its October meeting, the Pharmacovigilance and Risk Assessment Committee (PRAC) discussed three ongoing referrals in the EU. The PRAC did not initiate or conclude a safety referral.

Further information is accessible under the link below.

CHMP News – September 2015

25.09.2015

At its September 2015 meeting, the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) recommended 19 new medicines for marketing authorisation. Also the CHMP recommended extensions of indication for six medicines.

Further information is accessible under the link below.

PRAC News – September 2015

11.09.2015

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways. The PRAC aims to review the available data on the benefits and risks of these medicines and issue an opinion on their marketing authorisations across the European Union.

further information is accessible under the link below.

European Medicines Agency starts a review of nasal and mouth sprays containing fusafungine

11.09.2015

The European Medicines Agency (EMA) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways such as sinusitis (sinus infection) and tonsillitis (inflammation of the tonsils caused by an infection).

Further information is accessible under the link below.

Information on the correct use of OTC emeregency contraception containing ulipristal acetate and levonorgestrel

10.09.2015

The emergency contraception for preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. There are two oral emergency contraceptives without prescription currently authorised in Croatia. In order to ensure its correct and safe use, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to inform healthcare providers and users with information related to the use of these medicines.

Further information is accessible under the link below.

Dear Healthcare Professional Letter on the correct use of Humalog 200 Units/ml KwikPen (insulin lispro) to minimise the risk of medication errors

10.09.2015

Ely Lilly d.o.o. Croatia, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is informing health care professionals on the new information on safe use of insulin lispro, the insulin analogue that is taken at meal times, available in the strength of 200 Units/ml (Humalog 200 Units/ml KwikPen) to treat the diabetes in adults.

Republic of Croatia signed the MEDICRIME Convention

04.09.2015

The Republic of Croatia signed on 3 September 2015 the MEDICRIME Convention that for the first time at the international level defines the counterfeiting of medicinal products and medical devices, as well as their manufacturing and placing on the market without marketing authorisation or compliance with safety requirements as a pharmaceutical crime.

Further information is accessible under the link below.

Dear Healthcare Professional Letter on the new recommendations due to a risk from increased blood pressure with the use of mirabegron (Betmiga)

04.09.2015

Astellas, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) is informing healthcare professionals on the new recommendations for use of mirabegron (Betmiga) due to a risk of increased blood pressure.

Further information and the Dear Healthcare Professional Letter is accessible under the link below.

Dear Healthcare Professional Letter on the new distribution procedure of education material with the aim to minimise the risk of post-injection syndrome associated with ZypAdhera olanzapine powder and solvent for prolonged-release suspension for injection

01.09.2015

Eli Lilly Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is informing healthcare professionals on the new distribution procedure of education material with the aim to minimise the risk of post-injection syndrome associated with the use of ZypAdhera (olanzapine powder and solvent for prolonged-release suspension for injection).

Further information and the Dear Healthcare Letter is accessible under the link below.

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