carboplatin
As the list published 23 Sept 2026 has it, binding since 19 Apr 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
- 23 Jan 1986
- PSUR frequency
- 5 years
- Data lock point
- 23 Jan 2027
- Submission date
- 23 Apr 2027
- 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
PSUR frequency and DLP were updated on 19/10/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 30/06/2021 DLP was udpated on 25/09/2019 Next DLP was amended on 19/10/2016 PRAC Representative was amended on 27/11/2015. EURD and DLP amended on 06/10/2015 Lead MS added on 31/07/2015.
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- Data lock point 23 Jan 2027Submission by 23 Apr 2027
- Data lock point 23 Jan 2032Submission by 22 Apr 2032
- Data lock point 23 Jan 2037Submission by 23 Apr 2037
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
carboplatin — every 5 years, data lock point 23 Jan 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
carboplatin — every 5 years, data lock point 23 Jan 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.