News and Educations

Follow up on the shortage of Propranolol Sandoz 40 mg tablets (propranolol)

01.07.2015

Following to the earlier notice on the Shortage of Propranolol Sandoz 40 mg tablets (propranolol) on the Croatian market, the marketing authorisation holder for this product, Sandoz d.o.o. has notified the Agency for Medicinal Products and Medical Devices of the shortage continuation.

The normalisation in the supply chain with Propranolol Sandoz 40 mg tablets is expected in August 2015.

More information is accessible under the link below.

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Notice on the expected shortage of Zoloft 50 mg film-coated tablets (sertraline)

01.07.2015

The marketing authorisation holder for Zoloft 50 mg film-coated tablets (sertraline), Pfizer Croatia d.o.o., has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the expected shortage of this medicine on the Croatian market. The shortage is due to the active substance, sertraline.

The normalisation of the supply chain with this medicinal product is expected by the end of 2015. There are other authorised medicinal products available with the same active substance on the Croatian market.

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Notice on counterfeit medicinal product Norditropin SimpleXx 10 mg/1,5 solution for injection on the market of Bosnia & Herzegovina

27.06.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from Novo Nordisk Croatia d.o.o. on the suspected counterfeit of Norditropin SimpleXx 10 mg/1.5 ml solution for injection (somatropin) on the market of Bosnia & Herzegovina. The following batches are affected by this suspected counterfeit: SC11255, expiry date 11/2016 and the batch CL70711, expiry date 08/2017. These batches are labelled in the Romanian language.

Based on the manufacturer’s investigation, Novo Nordisk, Denmark, these batches are not manufactured and released by this manufacturer and the suspected counterfeit has been confirmed.

All wholesalers and pharmacies are being warned to pay special attention when receiving medicinal products susceptible to counterfeiting and when selecting a supplier to check whether the holds to the good distribution practice and possesses a wholesale distribution license.
Also, patients who have procured their Norditropin SimpleXx in Bosnia & Herzegovina are warned to pay special attention to the batch they received.

More information is accessible under the link below.

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HALMED participated in the Pangea VIII operation against counterfeit medicines

20.06.2015

The Agency for Medicinal Product and Medical Devices (HALMED) participated in the international operation “Pangea VIII” conducted and co-ordinated by Interpol and implemented by police, customs, national agencies and other competent authorities for medicines around the world with the aim to fight sale of counterfeit medicines. According to the final report published in June 2015, in the action conducted from 9 to 16 June 2015 in 115 countries, operations of 2414 internet pages linked to sale of illicit and counterfeited medicines was discovered and stopped, 156 individuals involved in these illicit activities were arrested and approximately 20.7 million potentially dangerous medicines worth 543 million kuna was ceased.

Further information is accessible under the link below.

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Recommendations for variation application based on the signal safety assessment from the PRAC May 2015 meeting

17.06.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages recommendations for variation application based on the safety signal assessment adopted at the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) May 2015 meeting, as well as Croatian translations of these recommendations. The concerned active substances are fingolimod, latanoprost (Xalatan), leflunomid and natalizumab. The recommendations are available here.

From May 2015 the EMA has started with a simultaneous publication of recommendations in English and their translations in all official languages of the EU member states. Recommendations and translations are published by the EMA approximately three weeks after the PRAC meeting. The Croatian translation, beginning from the PRAC May 2015 meeting will be published on the HALMED webpages simultaneously with recommendations in English and Newsletter will also be sent to users.

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Notice on temporary discontinuation in the supply chain and use of the batch 718356 of Augmentin 1000 mg+200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

11.06.2015

GlaxoSmithKline d.o.o., the marketing authorisation holder for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) of a temporary discontinuation in the supply chain and use of the batch 718356 of this medicinal product due to a suspected quality defect.

The suspicion in a quality defect is following to an inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at the GSK manufacturing site in Worthing, UK. This discontinuation of the supply chain and use will be in effect by the end of the GMP audit.

According to HALMED’s data, this batch is no longer available in wholesalers in the Republic of Croatia.

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