News and Educations

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.

more

Information about temporary distribution and application interruption of the one batch of the medicinal product Sandostatin LAR 30

03.08.2012

On 2 August 2012, the Agency for Medicinal Products and Medical Devices received a report from a health care professional about the quality defect of the medicine, Sandostatin LAR 30 mg, batch S0151. The report about the quality defect is related to the suspension reconstitution procedure, during which, instead of a milky suspension, clumpy clusters had occurred, due to which the medicine had not been used.

Novartis Hrvatska d.o.o., the marketing authorisation holder for the medicinal product Sandostatin LAR 30 mg, upon HALMED's request initiated on 3 August 2012 a distribution and application interruption of the application of the suspect batch of the medicinal product Sandostatin LAR 30 mg. The Ministry of Health took samples of the suspect batch and forwarded it to the Agency for testing.

The application interruption means that the aforementioned batch of the medicinal product is being kept in the site where observed until the test results and additional safety evaluations have been completed by HALMED and it is not returned to the distributor or marketing authorisation holder. Thereby the cold supply chain is not being at risk, in case HALMED decides to release again the same batch on the market.

more

Information on the supply cessation of the Croatian market with the medicinal product Garasone eye/ear drops(gentamicin, betamethasone)

03.08.2012

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for the medicinal product Garasone eye/ear drops (gentamicin, betamethasone) has informed the Agency for Medicinal Products and Medical Devices about the supply cessation of the croatian market with the aforementioned product.

The supply cessation of the Croatian market with the aforementioned product is caused by a decision of the manufacturer Schering-Plough N.V., Heist-op-den-Berg, Belgium on the cessation of the manufacturing and distribution of the product at the global level, for commercial reasons, due to the unsustainability of the manufacturing process.

more

Information about the expected shortage of the medicinal product Tarka 180 mg/2 mg tablets with modified release (verapamil, trandolapril) and the medicinal product Tarka 240 mg/4 mg tablets with modified release (verapamil, trandolapril)

02.08.2012

Abbott laboratories d.o.o., the marketing authorisation holder forthe medicinal product Tarka 180 mg/2 mg tablets with modified release (verapamil, trandolapril) and the medicinal product Tarka 240 mg/4 mg tablets with modified release (verapamil, trandolapril) has informed the Agency for Medicinal Products and Medical Devices about the shortage of the aforementioned products onthe Croatian market. The aforementioned products belong to the group of medicines that are used to lower blood pressure (antihypertensives). The shortage is caused by a manufacturing delay at the Abbott GmbH & Co. KG manufacturing site in Ludwigshafen, Germany.

The supply normalisation of the market with the medicinal product Tarka 180 mg/2 mg tablets with modified release and the medicinal product Tarka 240 mg/4 mg tablets with modified release is expected in September 2012.

The public will be promptly informed about any new information on the availability of the medicinal product Tarka 180 mg/2 mg tablets with modified release and the medicinal product Tarka 240 mg/4 mg tablets with modified release.

more

HALMED announces transfer of parts of its undertakings to a new location

27.07.2012

In order to improve its business operations, the Agency for Medicinal Products and Medical Devices (HALMED) will transfer parts of its undertakings to an additional location.

As of Monday, 30 July 2012, HALMED will, apart from its former location at Ksaverska Street 4, Zagreb, operate also on a new location - Robert Frangeš Mihanović Street 9, Zagreb (Sky Office, Business Building).

As of Thursday, 16 August 2012, the documentation for medicinal products (authorisations, variations and renewals) and pharmacovigilance will be submitted to the new location in the Robert Frangeš Mihanović Street 9, whereas samples and the documentation for medical devices will be submitted at the former location at Ksaverska Street 4.

By this date, all the documentation, samples and mail will be delivered at the address Ksaverska Street 4, 10000 Zagreb.

All mail deliveries will continue to be at the address Ksaverska Street 4, 10000 Zagreb.

more

Information about the volontary recall of the stomach tube CH 18 medical device lot

26.07.2012

Medicina trgovina d.o.o., the holder of the registry enrollment of the medical device has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to urgently recall one lot of the stomach tube CH 18 medical device of the manufacturer Changshu Taining Medical Equipment Co. Ltd, China due to a suspected product quality defect. The LOT 20100120 is being recalled by this decision.

On 26 July 2012, HALMED received a report from a health care facility about an unopened, sterile packaging of the aforementioned product in which, through a protective folio, a strange body that may possibly cause a contamination of the product, was observed. Therefore, HALMED informed the holder of the enrollment registry, who from precautions decidet to recall the aformentioned lot.

In the Republic of Croatia has not been reported any adverse event associated with the described problem with the stomach tube CH 18 medical device.

more

The first meeting of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency took place

26.07.2012

The European Medicines Agency (EMA) held from 19 to 20 July 2012 in Brussels a founding meeting of the Pharmacovigilance and Risk Assessment Committee (PRAC). PRAC was founded according to the new pharmacovigilance legislation that came in effect in the European Union on July 2, 2012.

The Pharmacovigilance and Risk Assessment Committee (PRAC) will have an important role in monitoring the safety of medicines in the European Union and its functioning will be entirely transparent, which involves a proactive information publishing on safety issues, holding of public consultations and publishing of Committe's programmes and minutes held. The EMA's Executive Director, Professor Guido Rasi stated that PRAC with its actions would additionally reinforce the existing system of the safety of medicines for human use in the European Union.

The list of Committee's members and the programme of the founding meeting is available on the official webpages of the European Medicines Agency (EMA). The next meeting of the Pharmacovigilance and Risk Assessment Committee will take place in September this year.

By the date of accession, Croatia participates as an active observer with two delegates in the PRAC meetings, the Head of Agency, Viola Macolić Šarinić, MD, PhD, clinical pharmacologist and toxicologist and an Agency's expert, Marin Banovac, MPharm.

more

Information about the expected shortage of the medicinal product MST Continus 10 mg prolonged release tablets (morphine sulfate)

26.07.2012

Medis Adria d.o.o., the marketing authorisation holder for MST Continus 10 mg tablets with prolonged release (morphine sulfate) has informed the Agency for Medicinal Products and Medical Devices about the expected shortage of the aforementioned medicine on the Croatian market. This product has been used as a long term relief of postoperative and severe pain. The shortage is due to an increased consumption.

The normalisation of the market supply of the medicinal product MST Continus 10 mg prolonged release tablets is expected by the end of September 2012.

The public will be promptly informed of any new information about the shortage of the medicinal product MST Continus 10 mg prolonged release tablets.

more

Information about the shortage of the medicinal product Neotigason 25 mg capsules (acitretin)

26.07.2012

Agmar d.o.o., the marketing authorisation holder has informed the Agency for Medicinal Products and Medical Devices about the shortage of the aforementioned product on the croatian market. This medicine has been used for the treatment of dermal diseases incuding psoriasis, ichthyosis and keratosis (Darier's disease). The reason for that shortage are production difficulties due to which the manufacturer Cenexi, Fontenay-Sous-Bois, France can not deliver the aforementioned medicine. On the 3rd July 2012, HALMED informed on its webpages about the shortage of the medicinal product Neotigason 10 mg capsules.

The normalisation of the market supply of the medicinal product Neotigason 25 mg capsules is expected in September 2012.

The public will be promptly informed of any new information about the shortage of the medicinal product Neotigason 25 mg capsules.

more

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.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives