trastuzumab
As the list published 23 Sept 2026 has it, binding since 6 Apr 2026. 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
- 25 Sept 1998
- PSUR frequency
- 3 years
- Data lock point
- 24 Sept 2027
- Submission date
- 23 Dec 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally authorised (CAP)
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
New CAP authorised on 30/06/2025 New CAP authorised on 19/09/2024 New CAP authorised on 15/11/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 29/06/2022 PSUR frequency and DLP were updated on 05/06/2019 New CAP authorised on 12/12/2018 PSUR Frequency amended and DLP updated on 26/04/2017 Next DLP was amended on 03/05/2016 The Next DLP was amended on 29/10/2015 Next DLP was amended on 16/07/2015, and the 1-yearly cycle PSUR should be submitted after the current Next DLP (24/09/2015). Next DLP was amended on 04/11/2014 Next DLP was amended on 02/05/2014
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- Data lock point 24 Sept 2027Submission by 23 Dec 2027
- Data lock point 24 Sept 2030Submission by 23 Dec 2030
- Data lock point 24 Sept 2033Submission by 23 Dec 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.
Combinations containing this substance
In earlier versions of the list
EMA/630645/2012 Rev.164 · published 23 Sept 2026
trastuzumab — every 3 years, data lock point 24 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
trastuzumab — every 3 years, data lock point 24 Sept 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.