trofinetide
New in the list published 23 Sept 2026; binds from 23 Mar 2027.
What the list says
- EU reference date
- 20 Aug 2026
- PSUR frequency
- 6 months
- Data lock point
- 19 Feb 2027
- Submission date
- 30 Apr 2027
- Next data lock point
- 19 Aug 2027
- Next submission date
- 28 Oct 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 20/08/2026
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 19 Feb 2027Submission by 30 Apr 2027
- Data lock point 19 Aug 2027Submission by 28 Oct 2027
- Data lock point 19 Feb 2028Submission by 29 Apr 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
trofinetide — every 6 months, data lock point 19 Aug 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.