Marketing authorisations for unmet medical needs: A critical appraisal of regulatory pathways in the European Union

Author:

Manellari Sara,Musazzi Umberto M.ORCID,Rocco Paolo,Minghetti Paola

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference49 articles.

1. European Medicines Agency (EMA), 2005a. Aptivus®: EPAR – Scientific Discussion. Available on the website: https://www.ema.europa.eu/en/documents/scientific-discussion/aptivus-epar-scientific-discussion_en.pdf. Last access: 30/11/2022.

2. European Medicines Agency (EMA), 2005b. Zevalin®: EPAR – Scientific Discussion. Available on the website: https://www.ema.europa.eu/en/documents/scientific-discussion/zevalin-epar-scientific-discussion_en.pdf. Last access: 30/11/2022.

3. European Medicines Agency (EMA), 2011a. Caprelsa®: EPAR – Public Assessment report. Available on the website: https://www.ema.europa.eu/en/documents/assessment-report/caprelsa-epar-public-assessment-report_en.pdf. Last access: 30/11/2022.

4. European Medicines Agency (EMA), 2011b. Public statement on Onsenal®: Withdrawal of the marketing authorisation in the European Union. Available on the website: https://www.ema.europa.eu/en/documents/public-statement/public-statement-onsenal-celecoxib-withdrawal-marketing-authorisation-european-union_en.pdf. Last access: 30/11/2022.

5. European Medicines Agency (EMA), 2012a. Public statement on Rilonacept Regeneron®: Withdrawal of the marketing authorisation in the European Union. Available on the website: https://www.ema.europa.eu/en/documents/public-statement/public-statement-rilonacept-regeneron-withdrawal-marketing-authorisation-european-union_en.pdf. Last access: 30/11/2022.

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