flucloxacillin
As the list published 23 Sept 2026 has it, binding since 16 Jun 2021. 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 Jan 1971
- PSUR frequency
- 8 years
- Data lock point
- 3 Mar 2028
- Submission date
- 1 Jun 2028
- 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?
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
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 16/12/2020 DLP was updated on 18/11/2020 PRAC representative was added on 06/05/2020 EURD updated on 25/09/2019 LMS was added on 31/07/2019
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- Data lock point 3 Mar 2028Submission by 1 Jun 2028
- Data lock point 3 Mar 2036Submission by 1 Jun 2036
- Data lock point 3 Mar 2044Submission by 1 Jun 2044
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
flucloxacillin — every 8 years, data lock point 3 Mar 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
flucloxacillin — every 8 years, data lock point 3 Mar 2028
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.