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det offentliga europeiska utredningsprotokollet (EPAR) (EPAR)

European public assessment report [ENGLISH]

A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information. Abbreviated as EPAR.

det offentliga europeiska utredningsprotokollet (EPAR) [SWEDISH]

En uppsättning dokument som beskriver utvärderingen av ett läkemedel som godkänts via det centraliserade förfarandet och inklusive produktinformationen, publicerad på Europeiska läkemedelsmyndighetens webbplats. Europeiska offentliga bedömningsrapporter inkluderar produktinformationen.

2024-01-29

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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 https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  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 https://toolkit.ncats.nih.gov/glossary-2/

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