PIL — Neuraclair
PIL labeling artefact for Neuravastatin in Australia. Version 15.5. Language: it.
Artifact ID
LBL-007
Type
PIL
Product
Market
Australia
Version
15.5
Language
it
Status
Pending
Last Reviewed
2023-06-24
Included Statements (5)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-019 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2023-09-11 |
| STMT-020 | Safety | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-03-07 |
| STMT-021 | Safety | Core Data Sheet | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-09-07 |
| STMT-022 | PK | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-11-16 |
| STMT-023 | Safety | Core Data Sheet | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-05-20 |
Change History
Harmonisation to core label
Section 4.8 ADR update
Harmonisation to core label
Posology revision
New indication added
Harmonisation to core label