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panitumumab

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
3 Dec 2007
PSUR frequency
3 years
Data lock point
30 Sept 2025
Submission date
29 Dec 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

PSUR frequency amended and DLP updated on 03/05/2023 DLP was updated on 25/05/2022 DLP was updated on 26/05/2021 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 DLP was updated on 23/05/2017 PRAC Representative amended on 28/03/2017 Next DLP was amended on 03/05/2016 Conditional approval Next DLP was amended on 28/05/2014

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 1 Jan 2027, 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
PSUR frequency3 years5 years
Data lock point2025-09-302030-09-30
Submission date2025-12-292030-12-29
NotesPSUR frequency amended and DLP updated on 03/05/2023 DLP was updated on 25/05/2022 DLP was updated on 26/05/2021 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 DLP was updated on 23/05/2017 PRAC Representative amended on 28/03/2017 Next DLP was amended on 03/05/2016 Conditional approval Next DLP was amended on 28/05/2014PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency amended and DLP updated on 03/05/2023 DLP was updated on 25/05/2022 DLP was updated on 26/05/2021 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 DLP was updated on 23/05/2017 PRAC Representative amended on 28/03/2017 Next DLP was amended on 03/05/2016 Conditional approval Next DLP was amended on 28/05/2014

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The next three reports

  • Data lock point 30 Sept 2028Submission by 29 Dec 2028
  • Data lock point 30 Sept 2031Submission by 29 Dec 2031
  • Data lock point 30 Sept 2034Submission by 29 Dec 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

    panitumumab — every 5 years, data lock point 30 Sept 2030

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

    panitumumab — every 3 years, data lock point 30 Sept 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.

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