glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease)
As the list published 23 Sept 2026 has it, binding since 30 Nov 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
- 28 Sept 2012
- PSUR frequency
- 5 years
- Data lock point
- 28 Sept 2027
- Submission date
- 27 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
PSUR frequency amended and DLP updated on 31/05/2023 PRAC Rapporteur name was amended on 28/04/2022 PRAC representative was updated on 31/03/2021 DLP was updated on 03/06/2020 PRAC representative was updated on 25/09/2019 PRAC Rapporteur name was corrected on 03/04/2019 PRAC Rapporteur name was amended on 06/06/2018 PRAC Representative amended on 17/10/2017 PSUR Frequency amended and DLP updated on 26/04/2017 The name of the active substance was amended on 22/09/2016 Next DLP was amended on 03/05/2016 Next DLP amended on 04/11/2014 Next DLP amended on 02/05/2014
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- Data lock point 28 Sept 2027Submission by 27 Dec 2027
- Data lock point 28 Sept 2032Submission by 27 Dec 2032
- Data lock point 28 Sept 2037Submission by 27 Dec 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
glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease) — every 5 years, data lock point 28 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease) — every 5 years, data lock point 28 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.