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.
