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macitentan / tadalafil

As the list published 4 Feb 2026 has it, binding since 17 Jun 2026. 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
14 Oct 2024
PSUR frequency
1 year
Data lock point
14 Oct 2025
Submission date
23 Dec 2025
Next data lock point
13 Oct 2026
Next submission date
22 Dec 2026
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

Next DLP amended on 17/12/2025 New CAP authorised on 27/09/2024

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.

Changing
FieldApplies todayFrom the date above
Data lock point2025-10-142026-10-13
Submission date2025-12-232026-12-22
Next data lock point2026-10-132027-10-13
Next submission date2026-12-222027-12-22
NotesNext DLP amended on 17/12/2025 New CAP authorised on 27/09/2024DLP was amended on 27/05/2026

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The next three reports

  • Data lock point 13 Oct 2026Submission by 22 Dec 2026
  • Data lock point 13 Oct 2027Submission by 22 Dec 2027
  • Data lock point 13 Oct 2028Submission by 22 Dec 2028

Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 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

    macitentan / tadalafil — every 1 year, data lock point 13 Oct 2027

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

    macitentan / tadalafil — every 1 year, data lock point 13 Oct 2026

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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