atosiban
As the list published 23 Sept 2026 has it, binding since 19 Apr 2023. 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
- 20 Jan 2000
- PSUR frequency
- 5 years
- Data lock point
- 31 Jan 2029
- Submission date
- 1 May 2029
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally and nationally authorised (CAP and NAP)
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
PRAC representative was updated on 19/10/2022 PRAC representative was updated on 17/11/2021 DLP was updated on 20/10/2021 PRAC representative was updated on 25/09/2019 DLP was updated on 23/10/2018 Reference to NAP added on 25/09/2017 Next DLP was amended on 29/10/2015 PRAC Rapporteur name amended on
Track dates like these for your own products: a sample workspace, read-only, no account needed.
Try the demoThe next three reports
- Data lock point 31 Jan 2029Submission by 1 May 2029
- Data lock point 31 Jan 2034Submission by 1 May 2034
- Data lock point 31 Jan 2039Submission by 1 May 2039
Counted from the data lock point the list gives, on the cycle it states: the submission date is 90 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
atosiban — every 5 years, data lock point 31 Jan 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
atosiban — every 5 years, data lock point 31 Jan 2029
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.