Medicinal Products

Information about the expected shortage of medicinal products manufactured by Immunološki zavod d.d.


Taking account of the expiration of the manufacturing license of the holder Imunološki zavod d.d.d for producing medicinal products from blood/plasma and sera of animal origin, as well as bacterial vaccines, the manufacturer informed the Agency for Medicinal Products and Medical Devices (HALMED) about the currently disposable stocks of these medicines. Listed here are those affected by the shortage or whose shortage is expected due to their consumption by the end of 2013:

  • Albumin (human) 20% solution for infusion
  • Albumin (human) 20% solution for infusion
  • Albumin human 50 g/l solution for infusion
  • Tetanus vaccine (adsorbed), Imunološki zavod, 1 dose, suspension for injection
  • Tetanus vaccine (adsorbed), Imunološki zavod, 10 doses, suspension for injection
  • Diphtheria and tetanus vaccine (adsorbed), 10 doses, suspension for injection (up to 7 years)
  • Immunoglobulin (human) for i.v. use, 10 ml
  • Immunoglobulin (human) for i.v. use, 50 ml
  • Immunoglobulin (human) for i.v. use, 100 ml
  • Human tetanus immunoglobulin, 250 IU

In order to ensure an adequate supply of the Croatian market with these medicines, HALMED will based on a written application authorise import/entry of products without the Croatian marketing authorisation, provided that parallel products with the same active substances do not exist on the Croatian market.

Applications for granting authorisations for import/entry of products without marketing authorisations may be submitted even when the approved product has yet to be marketed.