tenoxicam
As the list published 23 Sept 2026 has it, binding since 19 Apr 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
- 20 Feb 1986
- PSUR frequency
- 5 years
- Data lock point
- 28 Feb 2026
- Submission date
- 29 May 2026
- 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 19/10/2022 PRAC representative was updated on 27/07/2022 DLP and PSUR frequency were updated on 17/11/2021 PRAC representative was updated on 30/06/2021 DLP was updated on 21/11/2018 PRAC Rapporteur name was updated on 04/07/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017 PRAC Rapporteur name updated on 04/02/2016 PRAC Representative amended on 27/11/2015. The Next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015
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- Data lock point 28 Feb 2031Submission by 29 May 2031
- Data lock point 29 Feb 2036Submission by 29 May 2036
- Data lock point 28 Feb 2041Submission by 29 May 2041
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
tenoxicam — every 5 years, data lock point 28 Feb 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
tenoxicam — every 5 years, data lock point 28 Feb 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.