midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures)
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
- 5 Sept 2011
- PSUR frequency
- 3 years
- Data lock point
- 9 Sept 2025
- Submission date
- 8 Dec 2025
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally and nationally authorised (CAP and 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
DLP was amended on 03/05/2023 DLP was updated on 03/06/2020 Reference to NAP added on 18/12/2019 PRAC Rapporteur name was amended on 23/10/2018 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and DLP updated on 26/04/2017 Next DLP was amended on 07/04/2016 Name of entry was amended on 06/10/2014
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 27 Nov 2026, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Substance | midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures) | midazolam (oromucosal solution or nasal routes of administration) |
| Data lock point | 2025-09-09 | 2028-09-09 |
| Submission date | 2025-12-08 | 2028-12-08 |
| Notes | DLP was amended on 03/05/2023 DLP was updated on 03/06/2020 Reference to NAP added on 18/12/2019 PRAC Rapporteur name was amended on 23/10/2018 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and DLP updated on 26/04/2017 Next DLP was amended on 07/04/2016 Name of entry was amended on 06/10/2014 | DLP was amended on 27/05/2026 |
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- Data lock point 9 Sept 2028Submission by 8 Dec 2028
- Data lock point 9 Sept 2031Submission by 8 Dec 2031
- Data lock point 9 Sept 2034Submission by 8 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
midazolam (oromucosal solution or nasal routes of administration) — every 3 years, data lock point 9 Sept 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures) — every 3 years, data lock point 9 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.