levosimendan
As the list published 23 Sept 2026 has it, binding since 3 Dec 2020. 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
- 22 Sept 2000
- PSUR frequency
- 5 years
- Data lock point
- 22 Sept 2029
- Submission date
- 21 Dec 2029
- 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 Rapporteur name was amended on 01/02/2023 PRAC Rapporteur name was amended on 22/09/2022 PSUR frequency and DLP were updated on 03/06/2020 PRAC Rapporteur name updated on 23/10/2018 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA number was amended on 06/10/2014
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- Data lock point 22 Sept 2029Submission by 21 Dec 2029
- Data lock point 22 Sept 2034Submission by 21 Dec 2034
- Data lock point 22 Sept 2039Submission by 21 Dec 2039
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
levosimendan — every 5 years, data lock point 22 Sept 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
levosimendan — every 5 years, data lock point 22 Sept 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.