immunological medicinal product
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- Any medicinal product consisting of vaccines, toxins, serums or allergen products: Vaccines, toxins and serums shall cover in particular agents used to produce active immunity (such as cholera vaccine, BCG, polio vaccine, smallpox vaccine), agents used to diagnose the state of immunity (including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin) and agents used to produce passive immunity (such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin). Allergen products shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
- Broader Term
- medicinal product
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