Skip to content
Kreastel
Opening soon

avelumab

As the list published 23 Sept 2026 has it, binding since 15 May 2024. 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
23 Mar 2017
PSUR frequency
3 years
Data lock point
22 Mar 2026
Submission date
20 Jun 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

PSUR frequency amended and DLP updated on 15/11/2023

Track dates like these for your own products: a sample workspace, read-only, no account needed.

Try the demo

The next three reports

  • Data lock point 22 Mar 2029Submission by 20 Jun 2029
  • Data lock point 22 Mar 2032Submission by 20 Jun 2032
  • Data lock point 22 Mar 2035Submission by 20 Jun 2035

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

    avelumab — every 3 years, data lock point 22 Mar 2026

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    avelumab — every 3 years, data lock point 22 Mar 2026

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.

Kreastel