PIL — Glucovex
PIL labeling artefact for Glucovantib in Netherlands. Version 3.3. Language: pt.
Artifact ID
LBL-014
Type
PIL
Product
Market
Netherlands
Version
3.3
Language
pt
Status
Pending
Last Reviewed
2023-06-26
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-040 | Special Population | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2022-11-09 |
| STMT-041 | Efficacy | SmPC Section 5.1 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2022-12-07 |
| STMT-042 | Efficacy | SmPC Section 4.8 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-09-28 |
| STMT-043 | Interaction | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-23 |
| STMT-044 | Contraindication | SmPC Section 5.1 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-01-20 |
| STMT-045 | Interaction | SmPC Section 4.3 | The recommended dose is 10 mg once daily administered orally.… | 2024-06-16 |
| STMT-046 | PK | SmPC Section 4.4 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-09-30 |
| STMT-047 | Efficacy | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2022-12-29 |
| STMT-048 | Dosing | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2023-03-09 |
| STMT-049 | Contraindication | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-12-06 |
Change History