SPIRIVA

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

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 more about Tiotropium

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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