Spiolto Respimat 2,5 mikrograma/2,5 mikrograma, otopina inhalata
Name | Spiolto Respimat 2,5 mikrograma/2,5 mikrograma, otopina inhalata |
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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 |