sodium oxybate (intravenous use)
As the list published 23 Sept 2026 has it, binding since 25 Dec 2025. 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
- 13 Jun 1961
- PSUR frequency
- 5 years
- Data lock point
- 12 Oct 2029
- Submission date
- 10 Jan 2030
- 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
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 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was updated on 25/05/2022 PSUR frequency and DLP were updated on 05/06/2019 DLP was updated on 06/06/2018 PRAC representative added on 17/10/2017 New entry added on 21/07/2017
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- Data lock point 12 Oct 2029Submission by 10 Jan 2030
- Data lock point 12 Oct 2034Submission by 10 Jan 2035
- Data lock point 12 Oct 2039Submission by 10 Jan 2040
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
sodium oxybate (intravenous use) — every 5 years, data lock point 12 Oct 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
sodium oxybate (intravenous use) — every 5 years, data lock point 12 Oct 2029
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.