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periodisk säkerhetsrapport (PSUR)

Periodic Safety Update Report [ENGLISH]

A report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation. Abbreviated as PSUR.

periodisk säkerhetsrapport [SWEDISH]

En rapport utarbetad av innehavaren av godkännandet för försäljning som beskriver den globala säkerhetserfarenheten med ett läkemedel vid en bestämd tidpunkt efter dess godkännande.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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