News and Educations

European Medicines Agency initiates a recall of certain batches of the medicinal product NovoMix 30 FlexPen and Penfill

25.10.2013

Due to a quality defect, certain batches of the medicinal product NovoMix 30 FlexPen and Penfill are being recalled from the market in the EU Member States where affected batches have been distributed. The affected batches are not on the Croatian market and therefore the recall does not concern the Croatian market. The affected batches have never been placed on the market in Croatia, because the product for the Croatian market is not released at the manufacturing site that released the affected batches that are being recalled in the EU. Also, the recalled batches have never been placed on the market via interventional or parallel entry/import. The supply of the Croatian market with this medicine is going smoothly and there are other batches on the market not affected with this quality defect and therefore no reason for concern.
Detailed information for doctors and patients who purchased the medicine out of the Croatian territory is uccessble under the following link.

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On-going work on the HALMED telecommunication infrastructure

25.10.2013

Due to the on-going works on the telecommunication infrastructure of the Agency for Medicinal Products and Medical Devices, as of 3 p.m. HALMED’s phone and fax numbers will be temporarily unavailable. The complete normalisation of the system is expected no later than Monday, 25 October 2013.
For urgent reporting that may lead to medicinal product or medical device recalls, please call on the mobile +385 99 264 6417 that will be available from 0 to 24 h.
Thank you for your understanding.

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Information about the expected shortage of medicinal products manufactured by Immunološki zavod d.d.

23.10.2013

Taking account of the expiration of the manufacturing license of the holder Imunološki zavod d.d.d for producing medicinal products from blood/plasma and sera of animal origin, as well as bacterial vaccines, the manufacturer informed the Agency for Medicinal Products and Medical Devices (HALMED) about the currently disposable stocks of these medicines. Under the following link you may find the products affected by the shortage or whose shortage is expected due to their consumption by the end of 2013.
In order to ensure an adequate supply of the Croatian market with these medicines, HALMED will based on a written application authorise import/entry of products without the Croatian marketing authorisation, provided that parallel products with the same active substances do not exist on the Croatian market.
Applications for granting authorisations for import/entry of products without marketing authorisations may be submitted even when the approved product has yet to be marketed.

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Information about the shortage of medicinal products Dacarbazine Pliva 100 mg lyophilisate for solution for injection or infusion and Dacarbazine 200 mg lyophilisate for solution for injection or infusion

23.10.2013

The marketing authorisation holder for medicinal products Dacarbazine Pliva 100 mg lyophilisate for solution for injection or infusion and Dacarbazine Pliva 200 mg lyophilisate for solution for injection and infusion, Pliva Hrvatska d.o.o., has informed the Agency for Medicinal Products and Medical Devices about the shortage of these medicines on the Croatian market. This shortage is due to manufacturing problems that are not associated with the quality, safety or efficacy of the product.
The normalisation of the market with these medicinal products is expected in January 2014 and the Agency will be promptly informed by the marketing authorisation holder about any new information.
There is no other authorised medicinal product with the same active substance on the Croatian market and requests for import/entry will be handled according to the legal exemption scheme for medicinal products without the Croatian marketing authorisation.

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Submission of the documentation for reporting and assessment of non-intervention trials

21.10.2013

According to the Medicinal Products Act (Official Gazette, No 76/13) and the Ordinance on pharmacovigilance (Official Gazette no 83/13), the Agency for Medicinal Products and Medical Devices (HALMED) is the competent authority for authorisation of non-intervention trials.
You may find detailed information about the submission of the documentation for reporting and assessment of the non-intervention trial under the following link.

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Instructions for applicants on requirements with regard to preparation and submission of electronic documentation for medicinal products in eCTD and NeeS formats

16.10.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has prepared a new version of instructions for applicants with regard to preparation and submission of electronic documentation for medicinal products in eCTD and NeeS formats. These instructions are accessible on HALMED’s web pages in the Medicinal products/Procedures for granting marketing authorisations/Useful information for applicants/Documentation, or under the following link.

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New restrictions on use of medicinal products containing ergot alkaloids

16.10.2013

The European Commission has adopted the Recommendations of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on restrictions on the use of medicinal products containing derivatives of ergot alkaloids. These restrictions refer only to dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine. These active substances may no longer be used in the following indications where the risks outweigh the benefits: symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer’s disease and other dementia), ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD, stage II), ancillary treatment of Reynaud’s syndrome, ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, acute retinopathies of vascular origin, prophylaxis of migraine headache, orthostatic hypotension and symptomatic treatment of veno-lymphatic insufficiency. This conclusion is based on the review of data indicating increased risk of fibrosis (formation of excessive connective tissue that may damage organs and organism structure) and ergotism (symptoms of ergot intoxication, as cramps and obstructions in blood circulation) after the use of these medicines.
You may find detailed information under the following link.

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Dear Healthcare professional Letter about the new contraindication and reminder for monitoring liver function when using agomelatine (Valdoxan/Thymanax 25 mg film-coated tablets

15.10.2013

Servier Pharma d.o.o., the marketing authorisation holder for medicinal products Valdoxan 25 mg film-coated tablets and Thymanex 25 mg film-coated tablets (agomelatine) is, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sending a letter to healthcare professionals to inform them about the introduction of a new contraindication and to remind them for a need for liver function monitoring with the use of agomelatine.
Deatiled information and the Dear Healthcare Professional Letter are available under the folowing link.

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