News and Educations

HALMED participated on the regional conference for promoting of MEDICRIME convention

24.06.2014

The regional conference for promoting the MEDICRIME Convention entitled “MEDICRIME Convention: A Key Tool Against Organised Crime” was organised by the Council of Europe and the Macedonian ministries of health and justice from 19 to 20 June 2014 in Skopje. The Head of Agency, Dr Viola Macolić Šarinić, MD, PhD and the Head of OMCL, Rajka Truban Žulj, MPharm participated at the Conference.
HALMED representatives participated also at the time when MEDICRIME Convention for fighting against counterfeit medicines and medical devices was drafted. The Convention was adopted on the 9th December 2010 by the Council of Ministers of the Council of Europe. By this Convention, the counterfeiting of medicines and medical device, as well as its manufacturing and placing on the market without adequate authorisation or conformity with the safety requirements are for the first time defined as criminal actions.
The Republic of Croatia is planning to ratify the Convention by autumn this year.
Detailed information is accessible under the link below.

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Information about the recovery of the supply chain with a batch of Engerix B for children 10 micrograms/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)

18.06.2014

Following to the Notice about the temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0,5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), published on the 3rd June 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the recovery of the supply chain with the batch AHBVC 262 CD of this medicine.
Detailed information is accessible under the link below.

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Information about counterfeited Kaletra (lopinavir, ritonavir) in Germany

17.06.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received an information about a suspected counterfeit of Kaletra (lopinavir, ritonavir) in Germany. This medicine is used in treatment of human immunodeficiency (HIV-1) infection.
The suspected counterfeited medicine has been reported by a parallel trade company from Germany, who discovered during the check up of purchased quantities a non-conformity in labelling of the outer package and the package leaflet with the information figuring on the original product packaging.
The following batches are affected by the suspected counterfeit: 276268D, 345118D, 336398D. The manufacturer’s investigation is in the course and further distribution of these batches from the stock has been suspended.
Detailed information is accessible under the link below

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Notice about shortage of Androgel 50 mg, gel in sachet (testosterone)

17.06.2014

The marketing authorisation holder for the medicinal product Androgel 50 mg, gel in sachet (testosterone), Hospitalija trgovina d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the shortage of this medicine on the Croatian market. The shortage is due to a manufacturing delay.
The normalisation of the supply chain is expected in the middle of July.
Taking account that there is no other medicinal product with the same pharmaceutical form, same active substance in the Republic of Croatia and in order to ensure an adequate and continued market supply with this medicine, the marketing authorisation holder will ensure a sufficient quantity of this medicine from another market with a partial approval from HALMED for legal exemption from the labelling and package leaflet in the Croatian language.

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Notice about shortage of Dexamethason Krka 0.5 mg tablets (dexamethasone)

17.06.2014

The marketing authorisation holder for Dexamethason Krka 0.5 mg tablets (dexamethasone), Krka – farma d.o.o, has informed the Agency for Medicinal Products and Medical devices (HALMED) about a shortage of this medicine on the Croatian market. The shortage is due to a manufacturing delay.
The normalisation of the supply chain is expected by the middle of July.
There is another authorised medicinal product with the same pharmaceutical form, same active substance on the Croatian market. For urgent cases, HALMED will, upon wholesaler’s request, approve enter/import of medicines without marketing authorisation in Croatia, but having the same active substance like the medicine affected with this shortage.

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Dear Healthcare Professionals Letter on potential life-threatening adverse reactions after accidental exposure to fentanyl-containing transdermal patches (Durogesic, Fentanil Sandoz, Matrifen, Fentagesic)

17.06.2014

Johnson&Johnson S.E. d.o.o., Sandoz d.o.o., Takeda Pharmaceuticals Croatia d.o.o. and Pliva Hrvatska d.o.o., marketing authorisation holders for fentanyl-containing transdermal patches, have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about on potential life-threatening adverse reactions after accidental exposure to these medicines.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

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European Medicines Agency starts review to evaluate risk of ibuprofen-containing medicines taken over long periods

17.06.2014

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).
The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time. There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.
Detailed information is accessible under the link below.

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HALMED is organising a regulatory and pharmacovigilance conference

17.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) is organising a regulatory and pharmacovigilance conference to be held from 11 to 12 November 2014 in Šibenik. The conference is intended for marketing authorisation holders in the Republic of Croatia (especially to those employed in regulatory affairs and pharmacovigilance), pharmacists, clinical pharmacologists, competent authorities for medicines and qualified persons for pharmacovigilance. The languages of the conference are Croatian and English.
The organiser will apply at the Croatian Medical Chamber and The Croatian Chamber of Pharmacy to obtain permanent education credits for attending the conference.
The conference programme and information related to registration for the conference will soon be available at the HALMED webpages.

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