Acopair 18 mikrograma, prašak inhalata, tvrde kapsule
| Name | Acopair 18 mikrograma, prašak inhalata, tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-567442892 |
| Active Substance | tiotropijev bromid |
| Composition | jedna kapsula sadrži 21,7 mikrograma tiotropij bromida što odgovara 18 mikrograma tiotropija. jedna isporučena doza (doza oslobođena iz nastavka za usta uređaja za inhalaciju NeumoHaler) sadrži 12 mikrograma tiotropija |
| Pharmaceutical Form | prašak inhalata, tvrda kapsula |
| Manufacturer | Ferrer Internacional S.A., Sant Cugat del Valles (Barcelona), Španjolska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 09.08.2024 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 31.08.2026* |
| Classification Number | UP/I-530-09/22-02/210 |
| Registration Number | 381-12-01/171-24-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R03BB04 |
| Marketing status | Not marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
