nerandomilast
New in the list published 26 Aug 2026; binds from 26 Feb 2027.
What the list says
- EU reference date
- 7 Oct 2025
- PSUR frequency
- 6 months
- Data lock point
- 6 Oct 2026
- Submission date
- 15 Dec 2026
- Next data lock point
- 6 Apr 2027
- Next submission date
- 15 Jun 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
EURD and DLP corrected on 26/08/2026 New CAP authorised on 15/07/2026
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 6 Oct 2026Submission by 15 Dec 2026
- Data lock point 6 Apr 2027Submission by 15 Jun 2027
- Data lock point 6 Oct 2027Submission by 15 Dec 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
nerandomilast — every 6 months, data lock point 6 Apr 2027
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.