News | News and Educations .: HALMED

Information about the shortage of the medicinal product Imazol Plus cream (clotrimazole, hexamidine)

08.11.2012

Medical Intertrade d.o.o., the marketing authorisation holder for the medicinal product Imazol Plus cream has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the shortage of the aforementioned product. The shortage is caused by a business decision to terminate the distribution and withdrawal of marketing authorisation upon delivery of the currently available product on stock.
There are other authorised medicinal products available in Croatia with clotrimazole as active substance.

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.

Information about the recall of the medicinal product Typhim Vi, solution for injection in pre-filled syringe, typhoid polysaccharide vaccine

14.09.2012

Medoka d.o.o., the marketing authorisation holder for the medicinal product Typhim Vi, solution for injection in pre-filled syringe, typhoid polysaccharide vaccine, has informed the Agency for Medicinal Products and Medical Devices about the recall of the aforementioned product from the Croatian market. All batches of the product are subject to recall, due to a reduced antigen content discovered during the product testing procedure.

Since the product is used in public health institutes, the marketing authorisation holder has informed the Croatian Institute for Public Health about the recall.

The recall will cause a shortage of the aforementioned vaccine. Upon the request of the authorised wholesaler, the Agency will approve by the normalisation of the market which is expected in the beginning of 2013, the import of the product under the legal exemption scheme.

The public will be duly informed of any new information about the affordability of the product.

News and Educations

Information about the shortage of the medicinal product Imazol Plus cream (clotrimazole, hexamidine)

New programme versions for processing applications for the import of medicinal products and medical devices under the legal exemption scheme

List of medicinal products whose marketing authorisation has been suspended or withdrawn

Newly approved medicinal products

The opening hours of the Registry office on 31 October, 2013

List of medicinal products whose marketing authorisation has been suspended or withdrawn

Newly approved medicinal products

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

Information about the recall of the medicinal product Typhim Vi, solution for injection in pre-filled syringe, typhoid polysaccharide vaccine

List of approved products with new active substances