Pharmacovigilance

No evidence that Fluad vaccine caused deaths in Italy - EMA Committee review reassures Member States over safety of flu vaccine

03.12.2014

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no evidence that Fluad, a flu vaccine manufactured by Novartis, has caused serious events including deaths in Italy. These reports led the Italian Medicines Agency (AIFA) to suspend the use of two batches of Fluad as a precautionary measure on 27 November 2014.

Fluad is authorised in the European Union (EU) in a number of Member States. For the current vaccination campaign in Italy, about 4 million doses of Fluad have been distributed. The vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain. Fluad is not on the Croatian market.

More information is accessible under the link below.

Dear Healthcare Professional Letter on the risk of lack of efficacy due to incorrect reconstitution and administration of Eligard (leuprorelin acetate depot injection)

03.12.2014

In agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), Astellas d.o.o. has sent a letter to heathcare professionals on the risk of lack of efficacy due to incorrect reconstitution and administration process of Eligard (leuprorelin acetate depot injection).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

Dear Healthcare Professional Letter on the important information on stickers on vials as precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib)

03.12.2014

Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important information on stickers on vials as a precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

Dear Healthcare Professional Letter on the new information aimed at the safe use including the Pregnancy prevention programme for Erivedge 150 mg hard capsules (vismodegib)

03.12.2014

Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important safety information with regard to teratogenic effects of Erivedge 150 mg hard capsules (vismodegib) and introduction of the Pregnancy prevention programme for this medicine.

More information and the Dear Healthcare Professional letter is accessible under the link below.

CMDh News – November 2014

02.12.2014

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a regulatory body representing EU Member States, has endorsed new recommendations on testosterone-containing medicines, valproate – containing medicines and related active substances, continued with the implementation of the outcome of the referral for Tazocin and medicinal product with associated names. and endorsed the new version of the Core SmPC/PL.

More information is accessible under the link below.

Pharmacovigilance Workshop: Risk Management, Electronic Reporting; XEVMPD updates

25.11.2014

The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates will be organised from on the 10 and 11 February 2015 in Zagreb.

Details on fees, venue of the workshop and registration are accessible in the registration form by which all interested participants may register. The workshop programme is accessible under the link below.

CHMP News – November 2014

24.11.2014

Ten new medicines have been recommended for approval among which two orphan medicinal products at the November 2014 meeting of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended extensions for indications for Inductos and Travatan and recommended a change in classification for the emergency contraceptive ellaOne. The CHMP concluded its review of Corlentor/Procoralan (ivabradine) and discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera.

More information is accessible under the link below.

European Medicines Agency released recommendations on the classification status of ellaOne

21.11.2014

The European Medicines Agency (EMA) on its webpages has published a press release on the recommendations that will be forwarded to the European Commission for final Decision concerning the classification status of ellaOne. The entire press release is accessible below.

Dear Healthcare Professional Letter on exfoliative dermatitisan and skin exfoliation in patients treated with ustekinumab (Stelara)

21.11.2014

Janssen in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) has sent a letter to healthcare professionals on the risk from exfoliative dermatitis in patients treated with uskelimumab (Stelara).

More information and the Dear Healthcare Professional Letter are accessible under the link below.

European Antibiotic Awareness Day

17.11.2014

The European Antibiotic Awareness Day (EAAD) is manifested on 18 November every year. This manifestation is organised by the European Centre for Diesease Control and Prevention (ECDC) aimed at raising awareness on microorganism resistance to antibiotics and importance of their rational use.

HALMED is monitoring from the close the antibiotic use in Croatia and appeals on their rational and correct use. The correct use of antibiotics will preserve their activity, enforce their clinical efficacy and reduce the potential for antibiotic resistance, thus in the end resulting in reuction in morbidity and mortality due to infections caused by resistant bacteria.

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