flubendazole

As the list published 23 Sept 2026 has it, binding since 3 Nov 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: 10 Mar 1980
PSUR frequency: 5 years
Data lock point: 4 Feb 2029
Submission date: 5 May 2029
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?

Yes — the list requires 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

Lead MS and PRAC Rapporteur name added on 26/07/2023 Entry re-activated on 03/05/2023 Entry re-activated on 21/10/2022 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 21/10/2022 DLP was updated on 17/10/2017 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

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The next three reports

Data lock point 4 Feb 2029Submission by 5 May 2029
Data lock point 4 Feb 2034Submission by 5 May 2034
Data lock point 4 Feb 2039Submission by 5 May 2039

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
flubendazole — every 5 years, data lock point 4 Feb 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
flubendazole — every 5 years, data lock point 4 Feb 2029

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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