Labeling — Fabricor
Labeling labeling artefact for Fabrizyme-β in Germany. Version 3.0. Language: nl.
Artifact ID
LBL-010
Type
Labeling
Product
Market
Germany
Version
3.0
Language
nl
Status
Submitted
Last Reviewed
2024-06-15
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
| STMT-032 | PK | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-01-21 |
| STMT-033 | Special Population | SmPC Section 4.4 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-06-14 |
| STMT-034 | Special Population | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-05-17 |
| STMT-035 | Dosing | SmPC Section 4.4 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-18 |
| STMT-036 | Safety | SmPC Section 4.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-03-19 |
| STMT-037 | PK | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-01-12 |
Change History
Harmonisation to core label
Updated section 4.4 — special warnings
Interaction section update
Harmonisation to core label