PIL — Mavacor
PIL labeling artefact for Mavacamtamex in Denmark. Version 5.4. Language: it.
Artifact ID
LBL-030
Type
PIL
Product
Market
Denmark
Version
5.4
Language
it
Status
Approved
Last Reviewed
2024-03-01
Included Statements (9)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-088 | Special Population | SmPC Section 4.2 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-04-20 |
| STMT-089 | PK | SmPC Section 5.1 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-10-23 |
| STMT-090 | Special Population | SmPC Section 4.3 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-04-02 |
| STMT-091 | PK | Core Data Sheet | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-04-14 |
| STMT-092 | PK | SmPC Section 4.4 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-02-17 |
| STMT-093 | Efficacy | SmPC Section 5.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-03-08 |
| STMT-094 | Safety | SmPC Section 4.4 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-12-30 |
| STMT-095 | Efficacy | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-11-20 |
| STMT-096 | Special Population | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-02 |
Change History
Section 4.8 ADR update
Section 4.8 ADR update
Updated section 4.4 — special warnings
Harmonisation to core label
Posology revision
Interaction section update