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KreastelMeridian Pharma B.V.Read only

Products

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

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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