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centralt godkänd produkt

centrally authorised product [ENGLISH]

A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union. 

centralt godkänd produkt [SWEDISH]

Ett läkemedel med ett enda försäljningstillstånd utfärdat av EU-kommissionen och giltigt i hela Europeiska unionen.


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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