tobramycin (nebuliser solution) (centrally authorised product only)
As the list published 4 Feb 2026 has it, binding since 12 Aug 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
- 18 Mar 2015
- PSUR frequency
- 3 years
- Data lock point
- 18 Sept 2025
- Submission date
- 17 Dec 2025
- 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
PSUR frequency amended and DLP updated on 31/05/2023 PSUR frequency and DLP were updated on 28/04/2021 DLP was updated on 06/05/2020 DLP updated on 30/04/2019 New CAP authorised on 18/02/2019 PSUR frequency amended and DLP updated on 23/10/2018 PRAC Rapporteur name was amended on 31/07/2018 DLP was updated on 07/05/2018 DLP was updated on 17/10/2017 Next DLP was amended on 26/04/2017 Next DLP was amended on 19/10/2016 DLP and next DLP were amended on 03/052016 New CAP authorised on 18/03/2015
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 27 Nov 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 |
|---|---|---|
| Data lock point | 2025-09-18 | 2028-09-18 |
| Submission date | 2025-12-17 | 2028-12-17 |
| Notes | PSUR frequency amended and DLP updated on 31/05/2023 PSUR frequency and DLP were updated on 28/04/2021 DLP was updated on 06/05/2020 DLP updated on 30/04/2019 New CAP authorised on 18/02/2019 PSUR frequency amended and DLP updated on 23/10/2018 PRAC Rapporteur name was amended on 31/07/2018 DLP was updated on 07/05/2018 DLP was updated on 17/10/2017 Next DLP was amended on 26/04/2017 Next DLP was amended on 19/10/2016 DLP and next DLP were amended on 03/052016 New CAP authorised on 18/03/2015 | DLP was amended on 27/05/2026 |
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- Data lock point 18 Sept 2028Submission by 17 Dec 2028
- Data lock point 18 Sept 2031Submission by 17 Dec 2031
- Data lock point 18 Sept 2034Submission by 17 Dec 2034
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
tobramycin (nebuliser solution) (centrally authorised product only) — every 3 years, data lock point 18 Sept 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
tobramycin (nebuliser solution) (centrally authorised product only) — every 3 years, data lock point 18 Sept 2025
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.