Medicinal Products

Dear Healthcare Professionals Letter about a restriction of use of hydroxyethyl-starch (HES): Tetraspan, Voluven and Volulyte

14.11.2013

B. Braun Adria d.o.o. and Fresenius Kabi d.o.o., the marketing authorisation holders for hydroxyethyl-starch-containing medicinal products (Tetraspan 60 and 100 mg/ml solution for infusion, Voluven 6% solution for infusion, Volulyte 6% solution for infusion) have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about new restrictions of use of hydroxyethyl-starch-containing medicinal products (HES) based on the benefits/risks ratio assessment carried out recently in the EU.
Detailed information and the Dear Healthcare Professional Letter are avaiable under the link below.

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Notice related to the information about centrally authorised medicinal products in the HALMED data base

30.10.2013

The Agency for Medicinal Products and Medical Devices (HALMED) hereby informs all its users that the data base on the HALMED web pages, alongside the information about medicinal products authorised by HALMED, from now on contains the information about centrally authorised products, authorised by the European Commission following the scientific evaluation by the European Medicines Agency (EMA).
You may find more information about the search of the medicinal product data base, as well as an overview of available data in the Medicinal Products/Database, or in the Medicinal Products/For Patients/Information about medicines – Database section.

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News from the CHMP and CMDh – October 2013

30.10.2013

The Co-ordination Group for the Mutual Recognition and Decentralised Procedure for Human Medicines (CMDh) has adopted the PRAC recommendations about restrictions of use of hydrxyethyl-starch containing solutions (HES) and restrictions of use of short acting beta agonists in obstetric indications.
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) confirmed its previous recommendations about the restriction of use of dihydroergotoxin and metoclopramide and recommended restriction of use of intravenous forms of nicardipine.
More information is accessible under the following link.

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Information about the counterfeited medicine Pegasys 180 microgram solution for injection seized in Germany

29.10.2013

A counterfeited medicine Pegasys 180 microgram solution for injection (peginterferon alpha-2a), originating from parallel import has been discovered in Germany. The counterfeited medicine is labelled as “batch B1299B03 EXP 07 2015”. The batch number indicated on the counterfeited medicine is the same as the batch number on the original medicine of the marketing authorisation holder Roche Registration Limited. Roche’s original batch B1299 has been distributed in several countries of the European Union, Pakistan and Australia. We emphasize that the original batch has not been distributed in Croatia. Also, HALMED has neither received any report to quality defect for this medicinal product nor information indicating that the suspected counterfeited medicine Pegasys might be on the market, therefore no concern.
Detailed information is accessible under the following link:

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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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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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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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The PRAC news – October 2013

14.10.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave new recommendations on its October 2013 meeting about the safe use of medicines in European Union Member States.
The PRAC has concluded that the benefits of combined hormonal contraceptives continue to outweigh their risks. The PRAC confirmed the recommendation that hydrohyethyl-starch (HES) solutions must no longer be used to treat patients with sepsis or burn injuries or critically ill patients. In addition, the review of valproate-containing medicines and related substances and their use in pregnant woman has started.
Detailed information is accessible under the following link.

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