PIL — Alzaclear
PIL labeling artefact for Alzabistat in United Kingdom. Version 15.0. Language: sv.
Artifact ID
LBL-008
Type
PIL
Product
Market
United Kingdom
Version
15.0
Language
sv
Status
Approved
Last Reviewed
2024-02-21
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-022 | PK | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-11-16 |
| STMT-023 | Safety | Core Data Sheet | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-05-20 |
| STMT-024 | Safety | SmPC Section 4.5 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-05-21 |
| STMT-025 | Safety | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-05-21 |
| STMT-026 | Contraindication | SmPC Section 4.8 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-06-16 |
| STMT-027 | Dosing | SmPC Section 4.5 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-04-05 |
| STMT-028 | PK | SmPC Section 4.5 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-02-03 |
| STMT-029 | Contraindication | SmPC Section 4.5 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-08-02 |
| STMT-030 | Efficacy | Core Data Sheet | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-06-07 |
| STMT-031 | Safety | SmPC Section 4.3 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-16 |
Change History
Section 4.8 ADR update
Updated section 4.4 — special warnings
Posology revision
Posology revision
Updated section 4.4 — special warnings