Spiriva 18 mikrograma, prašak inhalata, tvrde kapsule
| Name | Spiriva 18 mikrograma, prašak inhalata, tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-342114823 |
| Active Substance | tiotropijev bromid hidrat |
| Composition | jedna kapsula sadrži 22,5 mikrograma tiotropij bromid hidrata, što odgovara 18 mikrograma tiotropija jedna inhalacijska doza (doza oslobođena iz nastavka za usta HandiHaler uređaja za inhalaciju) sadrži 10 mikrograma tiotropija |
| Pharmaceutical Form | prašak inhalata, tvrda kapsula |
| Packaging [MA Number for Packaging] | 30 kapsula u blisteru i uređaj za inhalaciju HandiHaler, u kutiji [HR-H-342114823-01] 30 kapsula u blisteru, u kutiji [HR-H-342114823-02] 60 kapsula u blisteru, u kutiji [HR-H-342114823-03] 90 kapsula u blisteru, u kutiji [HR-H-342114823-04] |
| Manufacturer | Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Njemačka Boehringer Ingelheim France, Pariz, Francuska |
| Marketing Authorisation Holder | Boehringer Ingelheim Zagreb d.o.o., Radnička 40-5, Zagreb, Hrvatska |
| Marketing Authorisation Date | 29.03.2016 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/172 |
| Registration Number | 381-12-01/70-16-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | R03BB04 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
