dexlansoprazole, lansoprazole
As the list published 23 Sept 2026 has it, binding since 21 Mar 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
- 31 Dec 1990
- PSUR frequency
- 5 years
- Data lock point
- 31 Dec 2026
- Submission date
- 31 Mar 2027
- 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
DLP was updated on 21/09/2022 Next DLP was amended on 25/09/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 Name of active substance was amended on 08/01/2014 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 30/11/2012
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- Data lock point 31 Dec 2026Submission by 31 Mar 2027
- Data lock point 31 Dec 2031Submission by 30 Mar 2032
- Data lock point 31 Dec 2036Submission by 31 Mar 2037
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
dexlansoprazole, lansoprazole — every 5 years, data lock point 31 Dec 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
dexlansoprazole, lansoprazole — every 5 years, data lock point 31 Dec 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.