News and Educations

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.

more

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.

more

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.

more

HALMED announces the beginning of operations of its Registry Office at two locations

14.08.2012

We inform all our applicants that the Registry Office of the Agency for Medicinal Products and Medical Devices will operate, as of 16 August, 2012 on two locations.
The opening hours of the Registry Office at the current address in Ksaverska cesta 4 will be from 8.00 a.m. to 3.30 p.m., whereas the sample submission will be from 8.00 a.m. to 2.00 p.m.
Samples, the documentation for medical devices, documentation for Central Ethics Committee and all other documentation except the documentation for medicinal products (marketing authorisations, variations, renewals) and pharmacovigilance. For the submission of more than four applications, a meeting has to be scheduled at +385 1 4884 162.
The opening hours at the new location Ulica Roberta Frangeša Mihanovića 9 (Sky Office Building) is from 8.00 a.m. to 3.00 p.m.
The documentation for medicinal products (marketing authorisations, variations and renewals) and all the documentation for pharmacovigilance, including including that related to the authorised clinical trials (SUSAR, DSUR). For the submission of more than four applications, a meeting has to be scheduled at +385 1 4884 162.
All mail is to be delivered to the address Ksaverska cesta 4, HR-10 000 Zagreb.

more

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.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives