lenograstim
As the list published 23 Sept 2026 has it, binding since 28 Dec 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
- 11 Oct 1991
- PSUR frequency
- 5 years
- Data lock point
- 31 Oct 2027
- Submission date
- 29 Jan 2028
- 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 amended and DLP updated on 28/06/2023 PRAC representative was updated on 29/07/2020 DLP was updated on 01/07/2020 PRAC representative was updated on 03/06/2020 DLP updated and PRAC Rapporteur name amended on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Lead MS and PRAC Rapporteur name was added on 03/06/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015
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- Data lock point 31 Oct 2027Submission by 29 Jan 2028
- Data lock point 31 Oct 2032Submission by 29 Jan 2033
- Data lock point 31 Oct 2037Submission by 29 Jan 2038
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
lenograstim — every 5 years, data lock point 31 Oct 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
lenograstim — every 5 years, data lock point 31 Oct 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.