Pharmacovigilance

The recall of three batches of the medicinal product Glibenclamid Genericon 3,5 mg tablets

20.11.2012

Genericon Pharma, d.o.o., the marketing authorisation holder for the medicinal product Glibenclamid Genericon 3,5 mg tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to recall three batches (10A014, 10A16A and 10A16 B) of the medicinal product Glibenclamid Genericon 3,5 mg tablets, blister pack of 120 tablets, from the Croatian market.
The decision about the recall was taken after the analysis discovering a slight increase of the acidic acid content, alkyl esters of fatty acids and olefins. Even though toxic components have not been determined, it was decided to recall all the three batches affected by the aforementioned quality defect. The marketing authorisation holder has informed all Croatian distributers about the recall.

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Dear Pharmacist letter with instructions for dispensing one batch of the medicinal product Betazon 0,5 mg/g ointment

04.10.2012

The company “Jadran” - Galenski laboratorij d.d. (JGL), which is the marketing authorisation holder for Betazon 0,5 mg/g ointment, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to pharmacists with instructions for dispensing the batch 2162 of the aforementioned medicine due to the discovered print defect on the outer packaging of the single pack unit. You may view the text of the letter in the continuation of this information.

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Information on the recall of three batches of the medicinal product Natrii chloride infundibile, 100 ml solution for infusion

03.09.2012

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the Croatian Institute for Transfusin Medicine, the manufacturer and marketing authorisation holder for the medicinal product Natrii chloride infundibile, solution for infusion of 100 ml, information about the recall of three batches of the aforementioned medicinal product. The recall from the Croatian market of the batches 2301081, 2302081 and 2303081 is carried out due to the quality defect discovered during the product stability testing. Test results demonstrate a slight increase in pH value, as well as an increase in chloride content.

HALMED has not received any report of suspected quality defect or adverse reaction to aforementioned medicinal product.

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Letter to Health Care Professionals about the incorrect information on non-approved indication in the package information leaflet in English for the medicinal product Tyverb 250 mg film-coated tablets (lapatinib)

30.08.2012

GlaxoSmithKline d.o.o., the marketing authorisation holder for the medicinal product Tyverb 250 mg film coated tablets (lapatinib), has in collaboration with the Agency for Medicinal Products and Medical Devices sent out a letter to health care professionals about the incorrect information on the indication in the patient information leaflet in English located in the package of the product Tyverb. The patient information leaflet in Croatian attached outside the package, contains accurate and approved indication as well as other information related to safe prescribing and use of Tyverb 250 mg film-coated tablets in Croatia.

In the continuation of this information you may view the letter to the health care professionals.

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Information about the recall of two batches of the medicinal product BiCNU injection 100 mg (carmustinum)

24.08.2012

Agency for medicinal products and medical devices has received from the importer company, PharmaSwiss, d.o.o. , the information about the recall of two batches of the medicinal product BiCNU (carmustine for injection). The recall of batches 0L60782 and 1C00679 is carried out as a precautious measure due to a quality defect discovered during the product stability testing. Test results demonstrated a higher content of the drug substance with regard to quality requirements, due to an over excessive content of the drug product in a single vial.

The medicinal product BiCNU (carmustine for injection) has no marketing authorisation for the Croatian market and therefore it is imported via a legal exemption scheme for treatment of patients in health care settings.

The recall from the market is being carried out by the importer based on the information from the Bristol Myers Squibb Company, the marketing authorisation holder abroad.

The PharmaSwiss d.o.o. Company has informed all the wholesalers in Croatia about the recall. More so, all the hospitals who received the aforementioned batches have also been informed.In the Republic of Croatia, new batches of the medicinal product BiCNU injection 100 mg have been imported, who were manufactured at another site and therefore are not subject to recall. Therefore, a substitute batch is available to hospitals, so that patients will not remain without their therapy.

HALMED has not received any report to suspect in quality defect or adverse reaction to BiCNU injection 100 mg, however, it will continue to monitor the safe use of the product.

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Dear Health Care Professional Letter about the risk from stopper particles when preparing the medicinal product Taxotere (docetaxel) using inappropriate gauge needle

09.08.2012

Sanofy-aventis Croatia d.o.o. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to health care professionals about the risk of stopper particles when preparing the medicinal product Taxotere (docetaxel). The letter informs health care professionals about the usage of the appropriate gauge needle in order to avoid creating stopper particles.

You can view the letter in the information continuation.

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Torisel 30 mg concentrate and diluent for solution for infusion – information about the observed deviation at revalidation of the cleaning procedure

06.08.2012

Pfizer Croatia d.o.o. company has informed HALMED that a deviation at the revalidation of the cleaning procedure in the manufacturing site Ben Venue laboratories, OHIO, USA has been observed, which means that a presence of residual substances from the filling and cleaning procedure carried out in this manufacturing site has been notified.

Bearing in mind that until July 2010 in the aforementioned manufacturing site the diluent of the medicinal product Torisel 30 mg concentrate and diluent for solution for transfusion (temsirolimus) was produced, it cannot be excluded that the batches of the aforementioned product AG48/1X and AGBV/1F that had been released on the Croatian market as well as a larger number of other batches released in other countries, are not impacted by this deviation.

The manufacturer has carried out an initial risk assessment and based on calculations, determined that quantities of residual substances that may be potentially found in batches manufactured in this manufacturing site, may be far lower than quantities of residuals in medicinal products set out in regulatory guidelines.

We remind that health care professionals are required to report to HALMED every adverse reaction and every quality defect. Patients who developed an adverse reaction to a medicinal product may report it directly to HALMED with recommendation to consult their doctor or pharmacist about the continuation of their therapy.

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Important safety information on benefits and risks of calcitonin containing medicinal products

26.07.2012

The European Medicines Agency recommends a limited long-term use of calcitonin-containing medicines, which means suspension of intranasal formulations for the treatment of osteoporosis and new limited indications for for formulations that are used as injections or infusions for the treatment of Paget's disease. Untill the decision of the status of those medicines on the Croatian market, for which, according to the rules of the EU, a decision of the European Commission is needed, The Agency for Medicinal Products and Medical Devices (HALMED) brings recommendations for prescribers on the use of calcitonin-containing medicines.

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Review about the known risks of an abnormal heart rhythm regarding the use of azithromycin and other macrolide antibiotics

18.05.2012

HALMED is aware of the results of the study published in the New England Journal of Medicine, on May 17, 2012, that compared the risks of cardiovascular death in patients treated with various antibiotics, including azithromycin. Results of the study are expected, given that azithromycin, as the only medicine from the macrolide antibiotic class was compared with antibiotics from other classes. It has been previously known for macrolide antibiotics that they are associated with a serious abnormalities of the heart rhythm, which occure rarely and due to the high effectiveness of these medicines, the benefit risk ratio of their use remains positive.

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Information on the expected shortage of the medicinal product ImmuCyst 81 mg powder for suspension for intravesicular use, BCG for immunotherapy

17.05.2012

Medoka d.o.o., the marketing authorisation holder for the medicinal product ImmuCyst 81 mg powder for suspension for intravesicular use, BCG for immunotherapy has notified the Agency for Medicinal Products and Medical Devices about the expected shortage of this medicine on the Croatian market. The product manufacturer, Sanofi Pasteur Limited (Toronto, Canada) has temporarily disrupted the supply of the product Immucyst, due to which a global shortage is expected.

The available dosages of the medicinal product ImmuCyst in Croatia are not affected by the aforementioned disruption. The marketing authorisation holder will inform about the expected shortage all the healthcare facilities where the product is used.

The public will be informed in due time about every new information on the availability of the product.

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