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belzutifan

As the list published 4 Feb 2026 has it, binding since 5 Sept 2025. Each entry binds six months after its own publication date (Article 107c(7) of Directive 2001/83/EC).

What the list says

EU reference date
13 Aug 2021
PSUR frequency
6 months
Data lock point
12 Aug 2025
Submission date
21 Oct 2025
Next data lock point
12 Feb 2026
Next submission date
23 Apr 2026
Products covered
Centrally authorised (CAP)

Are PSURs required for products referred to in Articles 10(1), 10a and 16a of Directive 2001/83/EC?

No — the list does not require PSURs for these products.

The list asks this as one question for Articles 10(1), 10a and 16a together, and does not answer it for Article 14 at all. A PSUR may in any case be required at the request of a competent authority or as a condition of the marketing authorisation.

Notes in the list

New CAP authorised on 12/02/2025

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 23 Mar 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
Data lock point2025-08-122026-08-12
Submission date2025-10-212026-10-21
Next data lock point2026-02-122027-02-12
Next submission date2026-04-232027-04-23
NotesNew CAP authorised on 12/02/2025DLP was amended on 23/09/2026

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The next three reports

  • Data lock point 12 Aug 2026Submission by 21 Oct 2026
  • Data lock point 12 Feb 2027Submission by 23 Apr 2027
  • Data lock point 12 Aug 2027Submission by 21 Oct 2027

Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 days after the data lock point — 70 days for a cycle of twelve months or less, 90 days for a longer one, as GVP Module VII sets out.

In earlier versions of the list

  • EMA/630645/2012 Rev.164 · published 23 Sept 2026

    belzutifan — every 6 months, data lock point 12 Feb 2027

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    belzutifan — every 6 months, data lock point 12 Feb 2026

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 2026. Open the published file

Kreastel is a planning and oversight aid for pharmacovigilance obligations. It tracks dates like these for a marketing authorisation holder's own products.

Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.

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