Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
Profile: APIX Regulatory DocumentReference
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
author: SynthPharma AG
description:
Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.
content
Attachments
ContentType Url Size Hash Title Creation application/fhir+xml Binary: application/fhir+xml (5736 bytes base64) 4301 6cPKZV1qBKdpZA1grvBEOzE+VqA=epi-annotated-v1.xml 2027-01-11 10:00:00+0100