Skip to content
Kreastel
Opening soon

clofarabine

As the list published 23 Sept 2026 has it, binding since 25 Mar 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
29 May 2006
PSUR frequency
3 years
Data lock point
28 Dec 2026
Submission date
28 Mar 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?

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

DLP was amended on 25/09/2024 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 25/09/2024 PSUR frequency, DLP and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended were updated on 28/07/2021 DLP and PRAC representative were updated on 29/07/2020 Reference to NAP added on 01/07/2020 New CAP authorised on 14/11/2019 DLP and 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?" were updated on 31/07/2019 PRAC representative was updated on 03/06/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 31/07/2018 DLP updated and PRAC Rapporteur name amended on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Next DLP and PRAC Rapporteur name updated was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016

Track dates like these for your own products: a sample workspace, read-only, no account needed.

Try the demo

The next three reports

  • Data lock point 28 Dec 2026Submission by 28 Mar 2027
  • Data lock point 28 Dec 2029Submission by 28 Mar 2030
  • Data lock point 28 Dec 2032Submission by 28 Mar 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

    clofarabine — every 3 years, data lock point 28 Dec 2026

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

    clofarabine — every 3 years, data lock point 28 Dec 2026

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.

Kreastel