paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride

As the list published 23 Sept 2026 has it, binding since 22 Apr 2026. 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: 6 Jun 1980
PSUR frequency: 8 years
Data lock point: 7 Mar 2028
Submission date: 5 Jun 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

Active substance name was amended on 22/10/2025 DLP was updated on 18/11/2020 PRAC representative was added on 06/05/2020 LMS was added on 31/07/2019

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The next three reports

Data lock point 7 Mar 2028Submission by 5 Jun 2028
Data lock point 7 Mar 2036Submission by 5 Jun 2036
Data lock point 7 Mar 2044Submission by 5 Jun 2044

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
paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride — every 8 years, data lock point 7 Mar 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride — every 8 years, data lock point 7 Mar 2028

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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