Pharmacovigilance

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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New instructions for electronic ADR reporting in E2B standard (EudraVigilance)

28.05.2013

Agency for Medicinal Products and Medical Devices (HALMED) introduced on its web page new instructions for electronic ADR reporting in E2B standard (EudraVigilance). The instructions are available in the questions and answers form within the section Pharmacovigilance/Information for Marketing Authorisation Holders – Electronic Transmission of ICSRs/Electronic ADR reporting in E2B standard (EudraVigilance) – Questions and Answers, or under the link available in the continuation of this note.

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Important notice to Marketing Authorisation Holders and Clinical Trial Authorisation Holders in the Republic of Croatia on suspension of submitting SUSARs from the third countries to HALMED

27.05.2013

Marketing Authorisation Holders (MAHs) and Clinical Trial Authorisation Holders (CTAHs) in the Republic of Croatia are herewith informed that starting from 1 June 2013 the Agency for Medicinal Products and Medical Devices (HALMED) will cease to receive SUSARs from the third countries (EU and non-EU countries) involving medicinal products authorised for marketing in the Republic of Croatia or medicinal products in clinical trials in the Republic of Croatia seeing HALMED now has a direct access to EudraVigilance database of the European Medicines Agency (EMA), which makes all of these applications visible to the Croatian regulatory body for medicinal products, as well. Following the above, starting from 1 June 2013 Authorisation Holders must cease to submit SUSARs from the third countries to HALMED both electronically and in paper format.

Until 30 June 2013 Marketing Authorisation Holders must continue submitting to HALMED Individual Case Safety Reports (ICSRs) which have been created and submitted from the territory of the Republic of Croatia regardless of the seriousness of the suspected adverse reaction report (serious and non-serious) within 15 days from the date of receipt of the report. Starting from 1 July 2013 serious adverse reactions from the territory of the Republic of Croatia should be submitted to HALMED exclusively electronically within 15 days from the date of receipt of the report, while non-serious adverse reactions should be submitted within 90 days from the date of receipt of the report.

Clinical Trial Authorisation Holders should continue to electronically submit SUSARs from the clinical trials in the Republic of Croatia within 15 days (7 days respectively) from the date of receipt of the report. These reports stay in the national adverse reactions database and are not sent to EMA, whereas the Clinical Trial Authorisation Holder is obliged to submit them electronically to EudraVigilance CT module.

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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New scientific confirmation of the low risk of Guillain-Barréovog syndrome associated with the use of pandemic flu vaccine in the vaccination season 2009/2010

02.05.2013

According to the results of an extensive meta-analysis conducted in the USA and recently published in The Lancet magazine, monovalent inactivated vaccines against pandemic influenza AH1N1 are associated with a minor risk of Guillain-Barréovog syndrome (GBS). The aim of the research was to ascertain how great a risk can be associated with the use of the aforementioned vaccines in relation to the expected number of GBS cases.

GBS is a rare autoimmune disorder in which a person’s own immune system damages their nerve cells, causing muscle weakness and paralysis. It is very often associated with colds and other infections of the upper respiratory system, the flu (seasonal or any other) and syndromes similar to the flu and some infections of the digestive system.

A comprehensive analysis of the safety risks associated with the use of the vaccines, funded by the American government, analysed data obtained from six adverse event monitoring systems that included information on 23 million vaccinated people in the USA. The incidence rate ratio (IRR) for the development of GBS was 2.35 (95% CI 1.42 -4.01, p = 0.0003). With the assumption that the background rate of GBS is one case per 100,000 people a year, the incidence rate ratio means translates to about 1.6 excess cases of GBS per million people vaccinated.

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Continued information about the recall of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion

29.03.2013

The company PharmaSwiss d.o.o., the marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml solution for infusion, upon request of the Agency for Medicinal Products and Medical Devices is recalling the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion, due to a discovered quality defect.
The decision about the recall is based on the test results obtained by HALMED of the batch 2A74306, according to the announcement posted on 9 January, 2013.
All stocks of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion were, from 9 January 2013, according to the announcement on HALMED’s webpages, marked and recalled from stocks of hospital pharmacies and a ban on dispension of the batch to patients was in effect.
There are sufficient batches of the medicinal product Perfalgan 10 mg/ml on stock in Croatia, that are not affected by the suspected quality defect and recall from the market.

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Information about the temporary suspension of sales and administration of the batch 2821211 of the medicinal product Gemcitabin Pliva 200, powder for solution for infusion

29.03.2013

The company Pliva Hrvatska d.o.o., the marketing authorisation holder for the medicinal product Gemcitabin 200, powder for solution for infusion, has, upon the request of the Agency for Medicinal Products and Medical Devices (HALMED) initiated a temporary suspension of sales and administration of the product’s batch 2821211.
The procedure of temporary suspension of sales and administration of the above mentioned products’s batch has been initiated after HALMED received a quality defect report from a health care professional on 29 March, 2013, who had discovered a glass particle of 5 mm in the product vial.
The existing stock of the batch remain on the market. However, they should not be dispensed or administered. HALMED has requested sampling from the Ministry of Health and samples will be submitted to HALMED for testing. The suspension of the administration of the aforementioned batch will be in effect as long as quality control results have not been gathered as well as other safety reviews by HALMED have not been completed, about which HALMED will inform the public.
The marketing authorisation holder has informed wholesalers and health care professionals about the suspension of sales and administration of the aforementioned product batch.

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Dear Health Care Professional Letter about the recall of medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin) from the Croatian market

08.03.2013

Novartis Hrvatska d.o.o., the marketing authorisation holder for medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin), has i n collaboration with the Agency for Medicinal Products and Medical Devicesd (HALMED) sent out a letter to health care professionals about the new information associated with the use of calcitonin. Due to a risk of malignant diseases with a long term use of the product, Miacalcic 200 IU nasal spray, solution has been withdrawn from the market, whereas Miacalcic 100 IU/ml solution for injection has been withdrawn from commercial reasons.

You may view the the Dear Health Care professional Letter in the continuation of this information.

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The European Medicines Agency has started a review of combined hormonal contraceptives containing chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate

08.02.2013

The European Medicines Agency (EMA) has started a review of several combined hormonal contraceptives that are authorised in the EU. Combined hormonal contraceptives contain two types of hormones, estrogen and progesterone (gestagen). This review includes all contraceptives containing the following gestagenes: chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin and norgestimate.

Detailed information you may find in the continuation of this information.

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