PIL — Glucovex
PIL labeling artefact for Glucovantib in Netherlands. Version 11.9. Language: nl.
Artifact ID
LBL-044
Type
PIL
Product
Market
Netherlands
Version
11.9
Language
nl
Status
Pending
Last Reviewed
2023-12-11
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-130 | Safety | SmPC Section 4.8 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-05-21 |
| STMT-131 | Safety | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-02-01 |
| STMT-132 | Contraindication | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-10-01 |
| STMT-133 | Contraindication | SmPC Section 5.2 | This product has been designated as an orphan medicine in the European Union.… | 2022-10-30 |
| STMT-134 | Safety | SmPC Section 4.8 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-05-13 |
| STMT-135 | Safety | SmPC Section 5.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-05-20 |
| STMT-136 | Contraindication | SmPC Section 4.3 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-05-14 |
| STMT-137 | Contraindication | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-18 |
| STMT-138 | PK | SmPC Section 4.5 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-10-17 |
| STMT-139 | Dosing | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-05-10 |
Change History
Interaction section update