fluticasone propionate / formoterol fumarate dihydrate
As the list published 4 Feb 2026 has it, binding since 30 Sept 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
- 23 Aug 2012
- PSUR frequency
- 5 years
- Data lock point
- 31 Jul 2026
- Submission date
- 29 Oct 2026
- 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
PSUR frequency and DLP were updated on 30/03/2022 PSUR frequency amended and DLP updated on 03/04/2019 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was amended on 07/04/2016 Lead MS was added on 13/07/2015
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 | PSUR frequency and DLP were updated on 30/03/2022 PSUR frequency amended and DLP updated on 03/04/2019 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was amended on 07/04/2016 Lead MS was added on 13/07/2015 | Not stated |
Track dates like these for your own products: a sample workspace, read-only, no account needed.
Try the demoThe next three reports
- Data lock point 31 Jul 2026Submission by 29 Oct 2026
- Data lock point 31 Jul 2031Submission by 29 Oct 2031
- Data lock point 31 Jul 2036Submission by 29 Oct 2036
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
fluticasone propionate / formoterol fumarate dihydrate — every 5 years, data lock point 31 Jul 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
fluticasone propionate / formoterol fumarate dihydrate — every 5 years, data lock point 31 Jul 2026
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.