Labeling — Ozanemax
Labeling labeling artefact for Ozanemolistat in Sweden. Version 2.3. Language: ja.
Artifact ID
LBL-056
Type
Labeling
Product
Market
Sweden
Version
2.3
Language
ja
Status
In Progress
Last Reviewed
2024-04-21
Included Statements (9)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-166 | Efficacy | SmPC Section 4.3 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-05 |
| STMT-167 | Special Population | SmPC Section 4.4 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-01-27 |
| STMT-168 | Dosing | SmPC Section 5.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-01-13 |
| STMT-169 | Contraindication | SmPC Section 4.3 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-08 |
| STMT-170 | Safety | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2022-11-08 |
| STMT-171 | Dosing | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-02-23 |
| STMT-172 | Efficacy | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-08-15 |
| STMT-173 | Contraindication | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-18 |
| STMT-174 | Interaction | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2024-04-04 |
Change History
Updated section 4.4 — special warnings
Interaction section update
New indication added
Harmonisation to core label
Interaction section update
Updated section 4.4 — special warnings