Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule
| Name | Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-818206056 |
| Active Substance | tiotropijev bromid |
| Composition | jedna kapsula sadrži 16 mikrograma tiotropijevog bromida što odgovara 13 mikrograma tiotropija jedna doza sadrži 10 mikrograma tiotropija po kapsuli |
| Pharmaceutical Form | prašak inhalata, tvrda kapsula |
| Packaging [MA Number for Packaging] | 15 kapsula u bočici i 1 inhalator, u kutiji [HR-H-818206056-01] 30 kapsula u bočici i 1 inhalator, u kutiji [HR-H-818206056-02] 60 kapsula (2 bočice od 30 kapsula) i 2 inhalatora, u kutiji [HR-H-818206056-03] 90 kapsula (3 bočice od 30 kapsula) i 3 inhalatora, u kutiji [HR-H-818206056-04] 30 kapsula u bočici u kutiji i 1 inhalator u kutiji [HR-H-818206056-05] |
| Manufacturer | Laboratorios Liconsa S.A., Azuqueca de Henares, Guadalajara, Španjolska Teva Pharma B.V., Haarlem, Nizozemska Actavis Limited, Zejtun, Malta Teva Operations Poland Sp. z o.o., Krakow, Poljska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 30.08.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/135 |
| Registration Number | 381-12-01/286-23-27 |
| 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 |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
