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
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.
Here you may view the dear Health Care Professional Letter.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.