Skip to content
Kreastel
Opening soon

vemurafenib

As the list published 4 Feb 2026 has it, binding since 3 Nov 2023. 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
17 Feb 2012
PSUR frequency
3 years
Data lock point
16 Aug 2025
Submission date
14 Nov 2025
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 03/05/2023 PRAC representative was updated on 19/10/2022 PSUR frequency and DLP was updated on 01/04/2020 DLP was updated on 03/04/2019 PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was amended on 07/04/2016 Next DLP was amended on 06/10/2014 Next DLP was amended on 01/04/2014 The DLP was corrected on 01/10/2013

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 2 Dec 2026, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
Data lock point2025-08-162028-08-16
Submission date2025-11-142028-11-14
NotesDLP was amended on 03/05/2023 PRAC representative was updated on 19/10/2022 PSUR frequency and DLP was updated on 01/04/2020 DLP was updated on 03/04/2019 PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was amended on 07/04/2016 Next DLP was amended on 06/10/2014 Next DLP was amended on 01/04/2014 The DLP was corrected on 01/10/2013Not stated

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 16 Aug 2028Submission by 14 Nov 2028
  • Data lock point 16 Aug 2031Submission by 14 Nov 2031
  • Data lock point 16 Aug 2034Submission by 14 Nov 2034

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

    vemurafenib — every 3 years, data lock point 16 Aug 2028

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

    vemurafenib — every 3 years, data lock point 16 Aug 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.

Kreastel