denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer)
As the list published 4 Feb 2026 has it, binding since 29 Dec 2022. 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
- 26 May 2010
- PSUR frequency
- 3 years
- Data lock point
- 26 Sept 2027
- Submission date
- 25 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 08/01/2026 New CAP authorised on 17/11/2025 New CAP authorised on 17/09/2025 New CAP authorised on 18/07/2025 New CAP authorised on 26/06/2025 New CAP authorised on 23/06/2025 New CAP authorised on 14/02/2025 New CAP authorised on 12/02/2025 New CAP authorised on 16/05/2024 PRAC Representative amended on 21/12/2022 PSUR frequency and DLP were updated on 29/06/2022 PSUR frequency and DLP were updated on 06/05/2020 DLP was updated on 30/04/2019 DLP was updated on 07/05/2018 Next DLP was amended on 26/04/2017 Next DLP was amended on 03/05/2016 Active Substance was amended on 31/07/2015 Next DLP was amended on 02/05/2014
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 | New CAP authorised on 08/01/2026 New CAP authorised on 17/11/2025 New CAP authorised on 17/09/2025 New CAP authorised on 18/07/2025 New CAP authorised on 26/06/2025 New CAP authorised on 23/06/2025 New CAP authorised on 14/02/2025 New CAP authorised on 12/02/2025 New CAP authorised on 16/05/2024 PRAC Representative amended on 21/12/2022 PSUR frequency and DLP were updated on 29/06/2022 PSUR frequency and DLP were updated on 06/05/2020 DLP was updated on 30/04/2019 DLP was updated on 07/05/2018 Next DLP was amended on 26/04/2017 Next DLP was amended on 03/05/2016 Active Substance was amended on 31/07/2015 Next DLP was amended on 02/05/2014 | Not stated |
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- Data lock point 26 Sept 2027Submission by 25 Dec 2027
- Data lock point 26 Sept 2030Submission by 25 Dec 2030
- Data lock point 26 Sept 2033Submission by 25 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.
In earlier versions of the list
EMA/630645/2012 Rev.164 · published 23 Sept 2026
denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) — every 3 years, data lock point 26 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) — every 3 years, data lock point 26 Sept 2027
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.