Medicinal Products

Dear Healthcare Professionals letter about the restriction of the use of the medicinal product Trobalt (retigabine) due to the risk of discolouration of eye tissues including retina, skin, lips and/or fingernails

19.08.2013

Glaxo Smith Kline d.o.o., the marketing authorisation holder for the medicinal product Trobalt (retigabine) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) issued a letter to healthcare professionals about the restriction of indications for the medicinal product due to a risk of discolouration of eye tissues, including retina, skin, lips and/or nailfingers.

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Information about the expected shortage of the medicinal product Anexate 0.5 mg/5 ml solution for injection or infusion (flumazenil)

14.08.2013

Roche d.o.o., the marketing authorisation holder for the medicinal product Anexate 0.5 mg/5 ml solution for injection or infusion (flumazenil), has informed the Agency for Medicinal Products and Medical Devices about the expected shortage of the aforementioned medicine on the Croatian market. The shortage is due to manufacturing problems.
The normalisation of the supply chain is expected by the end of October 2013. There will be another medicinal product available from the same therapeutic group, with the same active substance and pharmaceutical form for the treatment of Croatian patients.

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The information about the cessation of production and supply of the medicinal product Peptoran 300 mg film-coated tablets (ranitidine)

14.08.2013

Pliva (Croatia) d.o.o., the marketing authorisation holder for Peptoran 300 mg film-coated tablets (ranitidine), has informed the Agency for Medicinal Products and Medical Devices about the cessation of production and supply of the medicinal product Peptoran 300 mg film-coated tablets (ranitidine) and withdrawal of the marketing authorisation. The decision about the cessation of production is not due to quality, efficacy or safe use of the medicine. If their shelf-life has not expired, the available batches may remain on the Croatian market no longer than 18 months after the withdrawal of the marketing authorisation.
For the treatment of Croatian patients, there are other medicinal products from the same therapeutic group that are not affected by that shortage.

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News from PRAC – June 2013

17.06.2013

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) made four recommendations for the EU member states on four safety referrals at its June 2013 meeting.

Recommendations include further: restriction of the use of codeine for pain relief in children, the same precautions for diclofenac as for selective cox-2 inhibitors, the suspension of infusion solutions containing hydroxyethyl starch, the restriction of use of flupirtine-containing medicines.

Since these four PRAC recommendations concern medicinal products approved through national procedure, they will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

Detailed information can be found in the continuation of this notice.

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Adjustments to medicinal product information and risk minimization measures for medicinal products containing the active substances cyproterone acetate and ethinyl estradiol

13.06.2013

Summaries of the product characteristics and package leaflets of medicinal products containing cyproterone acetate and ethinyl estradiol will be aligned with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) endorsed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The recommendations are based on an assessment of the risks and benefits of the said medicinal products, published on the Agency for Medicinal Products and Medical Devices web site on 23 May 2013.

In the Republic of Croatia, marketing authorization has been granted for the following cyproterone- and ethinylestradiol-containing medicines:
1. Diane-35 coated tablets, marketing authorization holder Bayer d.o.o.
2. Bellune 35 coated tablets, marketing authorization holder Pliva Hrvatska d.o.o.
3. Axira 35 film coating tablets, marketing authorization holder Farmal d.d.

Detailed information can be found in the continuation of this notice.

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The benefits of Diane 35 and its generics outweigh the risks in certain patient groups

23.05.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (VTE and ATE – the formation of blood clots in the veins and arteries). These medicines should be used solely for the treatment of moderate to severe acne related to androgen sensitivity or hirsutism (excessive unwanted growth of facial hair) in women of reproductive age, as is already stated in the Summary of Product Characteristics and the Package Leaflet approved in the Republic of Croatia for these medicines.

The new recommendations by PRAC are not very different to the information that has already been approved for Diane 35 and its generics in Croatia. Based on the consumption data, HALMED estimates that these medicines have been consistently prescribed for the approved indications and no off-label use has been noted. So far, HALMED has not received any reports of adverse drug reactions with fatal effects related to the use of Diane 35 and its generics.

Detailed information can be found in the continuation of this notice.

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Information about the stopping of the medicinal product Vermox oral suspension 100 mg/5ml (mebendazol) production

22.03.2013

KRKA-FARMA d.o.o., the marketing authorisation holder for the medicinal product Vermox suspension 100 mg/5 ml (mebendazole) has informed the Agency for Medicinal Products and Medical Devices about the production stopping of the product.
There is no other authorised medicinal product for the same indication in Croatia. There is a possibility of a substitution therapy import under the legal exemption scheme for patients who need treatment with this product.

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Continued information about the shortage of the medicinal product Detrunorm XR 30 mg modified release capsules (propiverine)

21.03.2013

Merck, Sharp & Dohme d.o.o., the marketing authorisation holder for the medicinal product Detrunorm XR 30 mg modified release capsules (propiverine), hasd informed the Agency for Medicinal Products and Medical Devices about the shortage of this product on the Croatian market. HALMED reported about this shortage on 31 October 2013 on its webpages. The shortage is due to administrative reasons.

The normalisation of the supply chain with this medicinal product is expected in the third quarter of 2013. The medicinal product Detrunorm 15 mg coated tablets of the same manufacturer not affected by this shortage is available on the Croatian market.

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Volontary recall of the medical device OneTouch Verio®Pro – glycaemic self-management system intended for home and ambulatory care, manufactured by LifeScanEurope

19.03.2013

The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro – glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope – Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
Hereby we inform all users to stop using the product OneTouch®Pro – glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro – glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.
Further information is available in the continuation of this information.

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