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vildagliptin, metformin / vildagliptin

As the list published 4 Feb 2026 has it, binding since 23 Apr 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
26 Sept 2007
PSUR frequency
3 years
Data lock point
28 Feb 2027
Submission date
29 May 2027
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

Reference to NAP added on 23/10/2024 PRAC representative was updated on 19/10/2022 New CAP authorised on 24/03/2022 DLP was updated on 17/11/2021 DLP was updated on 23/10/2018 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name was amended on 31/07/2018 The Next DLP was amended on 29/10/2015 The active substance name was amended on 01/12/2014

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.

Changing
FieldApplies todayFrom the date above
NotesReference to NAP added on 23/10/2024 PRAC representative was updated on 19/10/2022 New CAP authorised on 24/03/2022 DLP was updated on 17/11/2021 DLP was updated on 23/10/2018 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name was amended on 31/07/2018 The Next DLP was amended on 29/10/2015 The active substance name was amended on 01/12/2014Not stated

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The next three reports

  • Data lock point 28 Feb 2027Submission by 29 May 2027
  • Data lock point 28 Feb 2030Submission by 29 May 2030
  • Data lock point 28 Feb 2033Submission by 29 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

    vildagliptin, metformin / vildagliptin — every 3 years, data lock point 28 Feb 2027

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    vildagliptin, metformin / vildagliptin — every 3 years, data lock point 28 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.

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