| Name |
Nintedanib Devatis 150 mg meke kapsule |
| Marketing Authorisation Number |
HR-H-805592546 |
| Active Substance |
nintedanibesilat |
| Composition |
jedna meka kapsula sadrži 150 mg nintedaniba (u obliku nintedanibesilata) |
| Pharmaceutical Form |
Kapsula, meka |
| Manufacturer |
Devatis GmbH, Loerrach, Njemačka |
| Marketing Authorisation Holder |
Devatis GmbH, Spitalstrasse 22, Loerrach, Njemačka |
| Marketing Authorisation Date |
17.09.2026 |
| MA Period of Validity |
17.09.2031 |
| Classification Number |
UP/I-530-09/25-01/240 |
| Registration Number |
381-12-01/171-26-08 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L01EX09 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Summary of risk management plan |
download |
