lenvatinib
As the list published 4 Feb 2026 has it, binding since 20 Apr 2022. 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 Feb 2015
- PSUR frequency
- 3 years
- Data lock point
- 12 Feb 2027
- Submission date
- 13 May 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally authorised (CAP)
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 updated on 23/02/2024 PRAC representative was updated on 19/10/2022 PSUR frequency and DLP were amended on 20/10/2021 DLP was updated on 23/09/2020 DLP was updated on 25/09/2019 DLP and PRAC Representative were updated on 26/09/2018 PSUR frequency amended and DLP updated on 27/03/2018 Next DLP was amended on 25/09/2017 PSUR Frequency amended and next DLP updated on 26/04/2017 PSUR Frequency amended and DLP updated on 28/03/2017 Next DLP was updated on 22/09/2016 Next DLP was amended on 07/04/2016 New CAP authorised on 28/05/2015.
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 2 Dec 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 |
|---|---|---|
| Notes | PRAC representative updated on 23/02/2024 PRAC representative was updated on 19/10/2022 PSUR frequency and DLP were amended on 20/10/2021 DLP was updated on 23/09/2020 DLP was updated on 25/09/2019 DLP and PRAC Representative were updated on 26/09/2018 PSUR frequency amended and DLP updated on 27/03/2018 Next DLP was amended on 25/09/2017 PSUR Frequency amended and next DLP updated on 26/04/2017 PSUR Frequency amended and DLP updated on 28/03/2017 Next DLP was updated on 22/09/2016 Next DLP was amended on 07/04/2016 New CAP authorised on 28/05/2015. | Not stated |
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- Data lock point 12 Feb 2027Submission by 13 May 2027
- Data lock point 12 Feb 2030Submission by 13 May 2030
- Data lock point 12 Feb 2033Submission by 13 May 2033
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
lenvatinib — every 3 years, data lock point 12 Feb 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
lenvatinib — every 3 years, data lock point 12 Feb 2027
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.