SPIRIVA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SPIRIVA contains one active pharmaceutical ingredient (API):

1 Tiotropium UNII L64SXO195N - TIOTROPIUM BROMIDE MONOHYDRATE

Tiotropium is a long-acting, specific, muscarinic receptor antagonist, in clinical medicine often called an anticholinergic. By binding to the muscarinic receptors in the bronchial smooth musculature, tiotropium inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine, released from parasympathetic nerve endings. Read about Tiotropium

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SPIRIVA Inhalation powder, hard capsule	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
SPIRIVA RESPIMAT Inhalation solution	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
R03BB04	Tiotropium bromide	R Respiratory system → R03 Drugs for obstructive airway diseases → R03B Other drugs for obstructive airway diseases, inhalants → R03BB Anticholinergics
Discover more medicines within R03BB04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10509D, 11043F, 11629C, 8626B
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 504504204135219
Country: CA	Health Products and Food Branch	Identifier(s): 02246793, 02435381
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 24.913-01-03, 29123-12-09
Country: EE	Ravimiamet	Identifier(s): 1511301, 1511312, 1511323, 1511334, 1511345, 1511367, 1513471, 1513482, 1513493
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 64796, 69589
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 005588, 005600, 021617, 038701, 099753, 119927, 516398
Country: FR	Base de données publique des médicaments	Identifier(s): 60363967, 62828920
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 121470, 139527, 139535, 143829, 143844, 302937, 33788, 33805, 373950, 376778, 377301, 377434, 394089
Country: HK	Department of Health Drug Office	Identifier(s): 50663, 51091, 57639
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-284647588, HR-H-342114823
Country: IE	Health Products Regulatory Authority	Identifier(s): 13205, 46811, 46913, 58405, 60453, 61468, 61500, 61503, 61504, 61509
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4874, 7759
Country: IT	Agenzia del Farmaco	Identifier(s): 035668058
Country: JP	医薬品医療機器総合機構	Identifier(s): 2259709G1027, 2259709G2023, 2259709G3020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004070, 1008917, 1008918, 1008919, 1018915, 1018916, 1025647, 1035424, 1086468, 1086469, 1086470, 1086471
Country: MT	Medicines Authority	Identifier(s): MA211/00201, MA211/00301
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 039M2002
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 59927, 84808
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10042, 13667
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100112888, 100217386
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W57488001, W57488002, W57488003, W57488004, W57488005, W57488006, W57488007, W58575005, W58575006, W58575007, W58575008
Country: SG	Health Sciences Authority	Identifier(s): 12238P, 13642P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 11533013, 11533014, 11533015
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699693550019
Country: US	FDA, National Drug Code	Identifier(s): 0597-0075, 0597-0100, 0597-0160, 50090-4248, 50090-4414
Country: ZA	Health Products Regulatory Authority	Identifier(s): 36/10.2.1/0044, 41/10.2.1/0849