News and Educations

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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Notice to applicants for submitting variations to the medicine’s documentation pursuant to the referral procedure for amoxicillin containing medicinal products

27.08.2015

The European Commission adopted on 20 August 2015 Commission implementing Decision concerning, in the framework of Article 30 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation for “Amoxil and associated names”, medicinal products for human use which contain the active substance “amoxicillin”(Procedure No EMEA/H/A-30/1372). Detailed information on this Decision is accessible on the European Commission website.

HALMED is inviting all marketing authorisation holders for amoxicillin-containing medicines in the Republic of Croatia, that are not listed in Annex I of Commissions Decision, to submit in the shortest time the application for variation to the medicine’s documentation.

Further information is accessible under the link below.

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Notice to applicants for variation applications to the medicine’s documentation pursuant to the referral procedure for adrenalin (epinephrine) –containing medicines

27.08.2015

The European Commission adopted on 14 August 2015 Decision on marketing authorisations for human medicines for adrenalin (epinephrine)-containing medicines for auto-injection within the framework of Art. 31 of Directive 2001/83/EC of the European Parliament and Council (Procedure No EMEA/H/A-31/1398). Detailed information on this Decision are accessible on the European Commission website.

HALMED invites all marketing authorisation holders in the Republic of Croatia for adrenalin (epinephrine)-containing medicines for auto-injection to submit in the shortest time an application for variation to the medicine’s documentation.

Further information is accessible under the link below.

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Follow-up notice on preventive recall of three batches of medicinal product Betrion mast (mupirocin)

25.08.2015

Following the increased public interest on recall of three batches of medicinal product Betrion mast (mupirocin), which HALMED reported about on 19 August 2015, we would like to inform the following:

Recall of batches No. 331104, 332104, 131084 of the medicinal product Betrion mast carried out by Pliva Croatia d.o.o., the marketing authorisation holder, has been conducted preventively to the wholesale level.

The recall was carried out due to suspicion that the active substance mupirocin, batch W656993, which was used in the production of batches listed above, might have been contaminated by penicillin during the manufacturing. However, examination of indicated batches of medicinal product did not show presence of any penicillin component. Therefore, the decision to recall the medicine to the level of wholesale has been made as a precautionary measure.

This suspected quality defect cannot cause serious health consequences for patients. Pharmacies may continue to issue the remaining supplies of these batches of medicinal product. Patients can continue to use batches listed above and there is no need for returning previously issued packagings of this medicinal product to pharmacies.

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Recall of three batches of the Betrion mast (mupirocin)

25.08.2015

Company Pliva Hrvatska d.o.o., the marketing authorisation holder of the Betrion mast (mupirocin), has notified Agency for Medicinal Products and Medical Devices (HALMED) about the recall of batches no. 331104, 332104, 131084 of this medicinal product, due to suspected quality defect.

The suspicion in quality defect is based on potential penicillin contamination of active substance batch no. W656993 which has been used in production of mentioned batches. The recall is carried out to the level of wholesales.

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Lecture „Regulatory procedures following the granting of the marketing authorisation“ within the Section for pharmaceutical regulations of the CPS

24.08.2015

Ms Jasna Ikić Komesar, MPharm, from the Agency for Medicinal Products and Medical Devices will hold a lecture "Regulatory procedures following the granting of the marketing authorisation" within the Section for pharmaceutical regulations of the Croatian Pharmaceutical Society (CPS). The lecture will be held on Tuesday, 15 September 2015 at 6.00pm at the premises of the CPS, Masarykova 2/II, Zagreb.

We invite the marketing authorisation holders and other interested parties who find the news in this field helpful in their work to attend this lecture.

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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.

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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.

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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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