Generated Narrative: DocumentReference docref-epi-annotated-v2

identifier: Document Set Identifier/urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc, Document Version Number Identifier/urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71

version: 2

status: Current

docStatus: Final

type: Labelling Comments

date: 2027-02-22 10:00:00+0100

author: Health Authority – Regulatory Review Division

RelatesTos

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*ReplacesDocumentReference: identifier = Document Set Identifier: urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc,Document Version Number Identifier: urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416; version = 1; status = current; docStatus = final; type = Proposed Labelling; date = 2027-01-11 10:00:00+0100; description = Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.

description:

Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3).

content

Attachments

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