ifosfamide
As the list published 4 Feb 2026 has it, binding since 30 Sept 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
- 13 Jul 1976
- PSUR frequency
- 8 years
- Data lock point
- 31 Jul 2028
- Submission date
- 29 Oct 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
PRAC Rapporteur name was amended on 22/09/2022 DLP was updated on 31/03/2021 PRAC representative was updated on 16/12/2020 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 2 Dec 2026, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Notes | PRAC Rapporteur name was amended on 22/09/2022 DLP was updated on 31/03/2021 PRAC representative was updated on 16/12/2020 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 | Not stated |
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- Data lock point 31 Jul 2028Submission by 29 Oct 2028
- Data lock point 31 Jul 2036Submission by 29 Oct 2036
- Data lock point 31 Jul 2044Submission by 29 Oct 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
ifosfamide — every 8 years, data lock point 31 Jul 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
ifosfamide — every 8 years, data lock point 31 Jul 2028
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.