Labeling — Pancrexan
Labeling labeling artefact for Pancrelipaze-R in India. Version 6.4. Language: sv.
Artifact ID
LBL-048
Type
Labeling
Product
Market
India
Version
6.4
Language
sv
Status
Pending
Last Reviewed
2023-07-09
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-142 | Contraindication | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-03-04 |
| STMT-143 | PK | Core Data Sheet | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-04-22 |
| STMT-144 | Contraindication | Core Data Sheet | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-04-03 |
| STMT-145 | Contraindication | SmPC Section 5.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-08-08 |
| STMT-146 | Interaction | SmPC Section 5.2 | Patients should be advised not to drive or operate machinery if they experience … | 2023-10-02 |
| STMT-147 | Special Population | SmPC Section 5.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-05-15 |
| STMT-148 | Safety | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2024-01-18 |
| STMT-149 | Safety | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2023-07-24 |
| STMT-150 | Special Population | SmPC Section 4.4 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-02-09 |
| STMT-151 | Safety | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2024-04-23 |
Change History
Harmonisation to core label
New indication added
Section 4.8 ADR update