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carbidopa / levodopa (only CAP for subcutaneous use)

New in the list published 23 Sept 2026; binds from 23 Mar 2027.

What the list says

EU reference date
19 Nov 2015
PSUR frequency
6 months
Data lock point
1 Oct 2026
Submission date
10 Dec 2026
Next data lock point
1 Apr 2027
Next submission date
10 Jun 2027
Products covered
Centrally authorised (CAP)

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 23/09/2026 Entry re-activated on 27/05/2026 New CAP authorised on 27/04/2026 Entry deleted as CAP surrendered 30/11/2019 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PSUR Frequency amended and DLP updated on 20/12/2016 New CAP authorised on 19/11/2015

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The next three reports

  • Data lock point 1 Oct 2026Submission by 10 Dec 2026
  • Data lock point 1 Apr 2027Submission by 10 Jun 2027
  • Data lock point 1 Oct 2027Submission by 10 Dec 2027

Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 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

    carbidopa / levodopa (only CAP for subcutaneous use) — every 6 months, data lock point 1 Apr 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.

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