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Off-label use of cardiovascular drugs as an indicator of therapeutic need in paediatrics
  1. Silvia Miriam Cammarata,
  2. Giacomo Capone
  1. Italian Medicines Agency, Roma, Lazio, Italy
  1. Correspondence to Dr Silvia Miriam Cammarata, Italian Medicines Agency, Roma, Italy; s.cammarata{at}

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The unapproved use of an approved drug is called ‘off-label’. In line with the European Medicine Agency’s pharmacovigilance directive, off-label “relates to situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorised product information (SmPC)”.1

The use of an off-label drug opens up a debate on one of the most delicate ethical aspects of medicine. The responsibility for the therapeutic choice and for the off-label use in some European countries, such as in Italy, falls on the prescriber who will have to ask the patient to sign an informed consent form which informs the patient appropriately about the pros and cons of the chosen therapy.

This use allows …

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  • Contributors SMC and GC collaborated in the planning, conduct, reporting, conception and design, acquisition of data or analysis and interpretation of data. Both authors read and approved the final manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.