Follow-up notice on reported suspected adverse reactions to the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose in Bosnia & Herzegovina


The Institute of Immunology d.d., marketing authorisation holder for the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the results of a quality control of the batch 78/3 of this vaccine with the expiry date by August 2015. The Institute of Immunology has received these results from the Agency for medicines and Medical Devices of Bosnia & Herzegovina within a conducted investigation following to suspected adverse reaction reports in Bosnia & Herzegovina, which was published on 31 December 2014 on the HALMED webpages.

It is concluded that the tested samples of the Tetanus vaccine (adsorbed) comply to the approved specification with regard to the tested parameters and therefore there are no obstacles to use other packs of the batch 78/3.