ispaghula husk, ispaghula husk / ispaghula seed, ispaghula husk / ispaghula seed / senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed
New in the list published 27 May 2026; binds from 27 Nov 2026.
What the list says
- EU reference date
- 13 Sept 1954
- PSUR frequency
- 10 years
- Data lock point
- 12 Sept 2034
- Submission date
- 11 Dec 2034
- 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
Entry re-activated on 27/05/2026 Active substance name was updated on 21/10/2020 New entry added on 25/09/2019
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- Data lock point 12 Sept 2034Submission by 11 Dec 2034
- Data lock point 12 Sept 2044Submission by 11 Dec 2044
- Data lock point 12 Sept 2054Submission by 11 Dec 2054
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
ispaghula husk, ispaghula husk / ispaghula seed, ispaghula husk / ispaghula seed / senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed — every 10 years, data lock point 12 Sept 2034
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.