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aliskiren, aliskiren / hydrochlorothiazide

As the list published 23 Sept 2026 has it, binding since 29 Dec 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
22 Aug 2007
PSUR frequency
3 years
Data lock point
30 Sept 2027
Submission date
29 Dec 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

DLP was updated on 29/06/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 25/09/2019 DLP updated on 30/04/2019 PRAC Rapporteur name amended on 04/07/2018 Entry name and DLP were updated on 07/05/2018 DLP was updated on 23/05/2017 Next DLP was amended on 03/05/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015

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The next three reports

  • Data lock point 30 Sept 2027Submission by 29 Dec 2027
  • Data lock point 30 Sept 2030Submission by 29 Dec 2030
  • Data lock point 30 Sept 2033Submission by 29 Dec 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

    aliskiren, aliskiren / hydrochlorothiazide — every 3 years, data lock point 30 Sept 2027

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

    aliskiren, aliskiren / hydrochlorothiazide — every 3 years, data lock point 30 Sept 2027

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.

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