SmPC — Tiotropex
SmPC labeling artefact for Tiotropizone in Spain. Version 9.6. Language: nl.
Artifact ID
LBL-043
Type
SmPC
Product
Market
Spain
Version
9.6
Language
nl
Status
Pending
Last Reviewed
2024-04-28
Included Statements (5)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-127 | Contraindication | SmPC Section 4.8 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-08-28 |
| STMT-128 | Dosing | SmPC Section 4.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-01-27 |
| STMT-129 | Efficacy | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-05-06 |
| 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 |
Change History
Harmonisation to core label
Updated section 4.4 — special warnings
Interaction section update
Harmonisation to core label