Nintedanib STADA 100 mg meke kapsule
| Name | Nintedanib STADA 100 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-798450739 |
| Active Substance | nintedanibesilat |
| Composition | jedna meka kapsula sadrži 100 mg nintedaniba u obliku nintedanibesilata |
| Pharmaceutical Form | Kapsula, meka |
| Manufacturer | AdAlvo Limited, San Gwann, Malta
Centrafarm Services B.V., Breda, Nizozemska Pharmadox Healthcare Limited, Paola, Malta STADA Arzneimittel GmbH, Beč, Austrija Qualimetrix S.A., Atena, Grčka STADA Arzneimittel AG, Bad Vilbel, Njemačka |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 18.01.2024 |
| MA Period of Validity | 18.01.2029 |
| Classification Number | UP/I-530-09/22-01/275 |
| Registration Number | 381-12-01/70-24-09 |
| 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 | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
