rilzabrutinib
As the list published 23 Sept 2026 has it, binding since 4 Aug 2026. 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
- 19 Jun 2025
- PSUR frequency
- 6 months
- Data lock point
- 18 Jun 2026
- Submission date
- 27 Aug 2026
- Next data lock point
- 18 Dec 2026
- Next submission date
- 26 Feb 2027
- 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 22/12/2025
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- Data lock point 18 Dec 2026Submission by 26 Feb 2027
- Data lock point 18 Jun 2027Submission by 27 Aug 2027
- Data lock point 18 Dec 2027Submission by 26 Feb 2028
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
rilzabrutinib — every 6 months, data lock point 18 Dec 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
rilzabrutinib — every 6 months, data lock point 18 Dec 2026
Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.164, published 23 Sept 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.