Skip to content
Kreastel
Opening soon

tenonitrozole

As the list published 23 Sept 2026 has it, binding since 27 Jul 2026. 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
11 Feb 1997
PSUR frequency
13 years
Data lock point
11 Feb 2028
Submission date
11 May 2028
Next data lock point
Not stated
Next submission date
Not stated
Products covered
Nationally authorised (NAP)

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

PRAC representative was updated on 31/05/2023 PRAC representative was updated on 31/03/2021 PRAC Rapporteur amended on 06/02/2019 PRAC Representative updated on 26/09/2018 PRAC Rapporteur amended on 28/02/2018 The PSUR Frequency and Next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015

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 11 Feb 2028Submission by 11 May 2028
  • Data lock point 11 Feb 2041Submission by 12 May 2041
  • Data lock point 11 Feb 2054Submission by 12 May 2054

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

    tenonitrozole — every 13 years, data lock point 11 Feb 2028

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

    tenonitrozole — every 13 years, data lock point 11 Feb 2028

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