lidocaine / norepinephrine

As the list published 23 Sept 2026 has it, binding since 6 Apr 2015. 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: 1 Oct 1948
PSUR frequency: 8 years
Data lock point: 30 Sept 2021
Submission date: 29 Dec 2021
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

PRAC representative and LMS were added on 03/03/2021

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The next three reports

Data lock point 30 Sept 2029Submission by 29 Dec 2029
Data lock point 30 Sept 2037Submission by 29 Dec 2037
Data lock point 30 Sept 2045Submission by 29 Dec 2045

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
lidocaine / norepinephrine — every 8 years, data lock point 30 Sept 2021
EMA/630645/2012 Rev.156 · published 4 Feb 2026
lidocaine / norepinephrine — every 8 years, data lock point 30 Sept 2021

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.

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