unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics;
unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with a summary of product characteristics for an authorised product or investigator's brochure for investigational products in clinical trails,
unexpected adverse reaction means, in respect of an investigational medicinal product, an adverse reaction, the nature or severity of which is not consistent with the information about that medicinal product as set out -
More Definitions of unexpected adverse reaction
unexpected adverse reaction means an Adverse Reaction, the nature or severity of which is not consistent with the applicable information concerning a Licensed Product or Demonstration Sample (e.g. Investigator’s Brochure for the Licensed Product).
unexpected adverse reaction means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out—
unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics or the investigator‘s brochure for medicinal products in clinical trials,
unexpected adverse reaction means an adverse reaction which is not mentioned in the summary of the product characteristics,
unexpected adverse reaction means any adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator’s brochure for an unapproved investigational product, or summary of product characteristics [Smock] for an authorised product).
unexpected adverse reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised investigational medicinal product or summary of product characteristics for an authorized product).
unexpected adverse reaction means an adverse reaction that is not identified among the possible adverse reactions in the circular of information.