Pharmacovigilance

CMDh News - September 2015

30.09.2015

At its September 2015 meeting, the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for Human Medicinal Products (CMDh) endorsed by consensus the PRAC recommendation for variations to marketing authorisations for several active substances.

The CMDh adopted the PRAC review conclusions for several active substances requiring changes in the product information or introduction of other risk minimisation measures.
Following the publication of the list of safety concerns per approved Risk Management Plans (RMPs) of active substances per product in April, the CMDh agreed to update the related cover note to provide guidance for Member States and MAHs on how to submit information for updates of the list. Templates for providing the information will also be made available.

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.

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.

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.

HALMED in the global top 10 according to the number of suspected adverse reaction reports per one million inhabitants

31.07.2015

According to the latest data published by the Uppsala Monitoring Centre (UMC), the collaborative center of the World Health Organisation (WHO) responsible for administering the global adverse reaction database VigiBase, the Republic of Croatia has become one of the ten countries in the world with the greatest number of suspected adverse reaction reports per one million inhabitants. This success is a result of common efforts of HALMED and all the health care professionals, patients and marketing authorisation holders who regularly report suspected adverse reactions.

Further information is accessible under the link below.

CHMP News – July 2015

24.07.2015

At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU) and therefore outside Croatia. In addition, ten new medicines have been recommended for approval, as well as four recommendations on extensions of therapeutic indication. The marketing authorisation holder for Heparesc has requested a re-examination of the CHMP’s June 2015 negative opinion and a review of Inductos has started.

Further information is accessible under the link below.

EMA to review Inductos

24.07.2015

The European Medicines Agency (EMA) has started a review of Inductos, an implant used in patients with spinal disc problems and leg fractures. This follows an inspection by Dutch and Spanish authorities which found the manufacturing site for one of the components of Inductos (the absorbable sponge) to be non-compliant with manufacturing requirements.

There is at present no indication of risk to patients linked to the inspection findings. This medicinal product is not placed on the Croatian market. EMA’s Committee for Medicinal Products for Human Use (CHMP) will now review the impact of the inspection findings on the product’s overall benefits and risks and make a recommendation as to whether any changes are needed to its marketing authorisation.

Further information is accessible under the link below.

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