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Periodic safety update reports and when they are due. · 5 products

ProductActive substanceMA numberDLPPSUR dueBasisStatusActions
Valerian root dry extract 500 mg tabletsvalerian rootPL/H/3391/00118 Mar 202627 May 2026Not required · Art. 16a — traditional herbal registrationNo PSUR requiredOpen: Valerian root dry extract 500 mg tablets
Levothyroxine sodium 50 microgram tabletslevothyroxine sodiumPL/H/1128/0021 Jul 202629 Sept 2026EURD list · Sample versionOverdue by 5 daysOpen: Levothyroxine sodium 50 microgram tablets
Metformin hydrochloride 1000 mg film-coated tabletsmetforminNL/H/2417/0012 Aug 202611 Oct 2026EURD list · Sample versionDue in 7 daysOpen: Metformin hydrochloride 1000 mg film-coated tablets
Rivaroxaban 20 mg film-coated tabletsrivaroxabanDE/H/5820/00114 Sept 202623 Nov 2026EURD list · Sample versionDue in 50 daysOpen: Rivaroxaban 20 mg film-coated tablets
Amlodipine / valsartan 5 mg/80 mg film-coated tabletsamlodipine / valsartanES/H/0463/0013 Nov 20261 Feb 2027Condition of the marketing authorisationDue in 120 daysOpen: Amlodipine / valsartan 5 mg/80 mg film-coated tablets
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Free text. Search the EURD list to take the substance's name and dates from it.

The article of Directive 2001/83/EC the marketing authorisation was granted under.

dd/mm/yyyyAlt and the down arrow open a calendar.

The data lock point the report is built from. Not needed for a product that raises no report.

Days from the data lock point to the due date.

Worked out from the legal basis and the EURD list. Search the list from the active substance above to have it answered.

Which version of the EURD list you read, for example 2026.07.

dd/mm/yyyyAlt and the down arrow open a calendar.

Only when the calculated date does not apply. A reason is required.

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