Labeling — Pancrexan
Labeling labeling artefact for Pancrelipaze-R in India. Version 19.3. Language: es.
Artifact ID
LBL-018
Type
Labeling
Product
Market
India
Version
19.3
Language
es
Status
In Progress
Last Reviewed
2023-11-19
Included Statements (4)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-052 | Contraindication | SmPC Section 4.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-23 |
| STMT-053 | Safety | SmPC Section 4.8 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2022-11-07 |
| STMT-054 | Safety | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-05-04 |
| STMT-055 | Dosing | SmPC Section 4.1 | This product has been designated as an orphan medicine in the European Union.… | 2023-11-27 |
Change History
Interaction section update
Harmonisation to core label
New indication added