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tenecteplase

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
23 Feb 2001
PSUR frequency
3 years
Data lock point
31 Aug 2025
Submission date
29 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 PSUR frequency and DLP were updated on 06/05/2020

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 29 Oct 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 point2025-08-312028-08-31
Submission date2025-11-292028-11-29
NotesDLP was amended on 03/05/2023 PSUR frequency and DLP were updated on 06/05/2020DLP was amended on 29/04/2026

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The next three reports

  • Data lock point 31 Aug 2028Submission by 29 Nov 2028
  • Data lock point 31 Aug 2031Submission by 29 Nov 2031
  • Data lock point 31 Aug 2034Submission by 29 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

    tenecteplase — every 3 years, data lock point 31 Aug 2028

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

    tenecteplase — every 3 years, data lock point 31 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.

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