Submit an MAA to the EMA for relugolix monotherapy for advanced prostate cancer
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 11 Feb 2021
- Due
- 31 Mar 2021
- Delivered
- 29 Mar 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) for relugolix monotherapy for advanced prostate cancer expected in the first quarter of calendar year 2021.”
What we found
Evidence strength A What the grades mean
Myovant Sciences announced on March 29, 2021, that the EMA had validated their previously submitted Marketing Authorization Application for relugolix monotherapy for advanced prostate cancer, confirming the submission occurred within the first quarter.
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A Myovant Sciences Ltd. 10-K filed 2021-05-11
“On March 29, 2021, we announced that the European Medicines Agency (“EMA”) validated our previously submitted Marketing Authorization Application (“MAA”) for relugolix for the treatment of men with advanced prostate cancer.” ✓ confirmed on the page
Checked 25 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- MAA submission for relugolix monotherapy
- Where
- Europe
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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