Labeling — Lorlacor
Labeling labeling artefact for Lorlatenilib in Turkey. Version 10.3. Language: pl.
Artifact ID
LBL-051
Type
Labeling
Product
Market
Turkey
Version
10.3
Language
pl
Status
In Progress
Last Reviewed
2023-07-29
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-151 | Safety | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2024-04-23 |
| STMT-152 | Safety | SmPC Section 4.3 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-07-18 |
| STMT-153 | Efficacy | SmPC Section 4.1 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2024-06-16 |
| STMT-154 | Dosing | SmPC Section 5.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2022-12-17 |
| STMT-155 | Contraindication | SmPC Section 4.3 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-09-18 |
| STMT-156 | Interaction | SmPC Section 5.1 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-02 |
| STMT-157 | PK | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-07-07 |
| STMT-158 | PK | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-11-13 |
| STMT-159 | Special Population | SmPC Section 4.8 | The recommended dose is 10 mg once daily administered orally.… | 2024-02-15 |
| STMT-160 | PK | SmPC Section 5.2 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-01-02 |
Change History
Updated section 4.4 — special warnings
New indication added
Posology revision
New indication added
Section 4.8 ADR update
Interaction section update