PIL — Ozanemax
PIL labeling artefact for Ozanemolistat in Sweden. Version 20.2. Language: fr.
Artifact ID
LBL-026
Type
PIL
Product
Market
Sweden
Version
20.2
Language
fr
Status
In Progress
Last Reviewed
2023-07-27
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-076 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2024-05-09 |
| STMT-077 | Dosing | SmPC Section 4.2 | This product has been designated as an orphan medicine in the European Union.… | 2023-10-29 |
| STMT-078 | Special Population | SmPC Section 4.1 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2024-02-02 |
| STMT-079 | PK | SmPC Section 4.2 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-10-16 |
| STMT-080 | Dosing | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2023-09-21 |
| STMT-081 | Efficacy | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-07-08 |
| STMT-082 | Safety | SmPC Section 4.5 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-09-02 |
| STMT-083 | Safety | SmPC Section 4.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-03-30 |
| STMT-084 | Contraindication | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2024-03-03 |
| STMT-085 | Interaction | Core Data Sheet | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-02-20 |
Change History
New indication added
Interaction section update
Harmonisation to core label
New indication added