semaglutide (treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis)
New in the list published 3 Jun 2026; binds from 3 Dec 2026.
What the list says
- EU reference date
- 26 Mar 2026
- PSUR frequency
- 6 months
- Data lock point
- 25 Sept 2026
- Submission date
- 4 Dec 2026
- Next data lock point
- 25 Mar 2027
- Next submission date
- 3 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
New CAP authorised on 26/03/2026
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- Data lock point 25 Sept 2026Submission by 4 Dec 2026
- Data lock point 25 Mar 2027Submission by 3 Jun 2027
- Data lock point 25 Sept 2027Submission by 4 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
semaglutide (treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis) — every 6 months, data lock point 25 Mar 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.