Spiolto Respimat 2,5 mikrograma/2,5 mikrograma, otopina inhalata
| Name | Spiolto Respimat 2,5 mikrograma/2,5 mikrograma, otopina inhalata |
|---|---|
| Marketing Authorisation Number | HR-H-852053792 |
| Active Substance | tiotropijev bromid hidrat olodaterolklorid |
| Composition | jedna inhalacijska doza sadržava 2,5 mikrograma tiotropija (u obliku bromidhidrata) i 2,5 mikrograma olodaterola (u obliku klorida) po potisku |
| Pharmaceutical Form | otopina inhalata |
| Manufacturer | Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Njemačka Boehringer Ingelheim Espana S.A., Sant Cugat del Valles (Barcelona), Španjolska Boehringer Ingelheim France, Pariz, Francuska |
| Marketing Authorisation Holder | Boehringer Ingelheim International GmbH, Binger Straße 173, Ingelheim am Rhein, Njemačka |
| Marketing Authorisation Date | 27.03.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/173 |
| Registration Number | 381-12-01/70-20-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | R03AL06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
