prasterone (vaginal use/Pessary)
As the list published 4 Feb 2026 has it, binding since 31 Jan 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
- 16 Nov 2016
- PSUR frequency
- 2 years
- Data lock point
- 15 Nov 2025
- Submission date
- 13 Feb 2026
- Next data lock point
- Not stated
- Next submission date
- Not stated
- 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
DLP was amended on 31/07/2024
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 29 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| PSUR frequency | 2 years | 5 years |
| Data lock point | 2025-11-15 | 2030-11-15 |
| Submission date | 2026-02-13 | 2031-02-13 |
| Notes | DLP was amended on 31/07/2024 | PSUR frequency amended and DLP updated on 29/07/2026 |
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 15 Nov 2027Submission by 13 Feb 2028
- Data lock point 15 Nov 2029Submission by 13 Feb 2030
- Data lock point 15 Nov 2031Submission by 13 Feb 2032
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
prasterone (vaginal use/Pessary) — every 5 years, data lock point 15 Nov 2030
EMA/630645/2012 Rev.156 · published 4 Feb 2026
prasterone (vaginal use/Pessary) — every 2 years, data lock point 15 Nov 2025
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.