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miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole

As the list published 4 Feb 2026 has it, binding since 17 Jun 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
31 Jul 1971
PSUR frequency
10 years
Data lock point
9 Oct 2034
Submission date
7 Jan 2035
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 17/12/2025 DLP was amended on 25/06/2025

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 2 Dec 2026, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
NotesActive substance name was amended on 17/12/2025 DLP was amended on 25/06/2025Not stated

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The next three reports

  • Data lock point 9 Oct 2034Submission by 7 Jan 2035
  • Data lock point 9 Oct 2044Submission by 7 Jan 2045
  • Data lock point 9 Oct 2054Submission by 7 Jan 2055

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

    miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole — every 10 years, data lock point 9 Oct 2034

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole — every 10 years, data lock point 9 Oct 2034

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 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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