Medicinal Products

Spiriva 18 mikrograma, prašak inhalata, tvrde kapsule

Name Spiriva 18 mikrograma, prašak inhalata, tvrde kapsule
Marketing Authorisation Number HR-H-342114823
Active Substance tiotropii bromidum
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, Paris, 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
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