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01 1Apotex Inc
02 22Boehringer Ingelheim GmbH
03 1Lupin Ltd
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01 3CAPSULE
02 2Inhalasjonsvaeske, resolution
03 3Inhalation liquid, solution
04 1Olodaterolo 2,5Mcg 30 Units - Respiratory Use
05 3SOLUTION
06 2SPRAY, METERED;INHALATION
07 2Solution
08 7Solution For Inhalation
09 1Tiotropium+Olodaterolo+2,52.5 Mcg 60 Doses Respiratory Use
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01 2Allowed
02 3Approved
03 4Authorized
04 6Prescription
05 2RX
06 7Blank
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01 1APO-TIOTROPIUM
02 1Heavy overnight value Respimat
03 2INSPIOLTO RESPIMAT
04 1Iolto Reactor
05 1LUPIN-TIOTROPIUM
06 1SPIRIVA
07 1SPIRIVA RESPIMAT
08 1STIOLTO RESPIMAT
09 1STRIVERDI RESPIMAT
10 7Spiolto Respimat
11 1Spiolto Respimat
12 1Sterdi Reactor
13 3Striverdi Respimat
14 2Yanimo Respimat
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01 6Canada
02 2Italy
03 5Norway
04 4Spain
05 3Sweden
06 2Switzerland
07 2USA
Regulatory Info : Prescription
Registration Country : Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
Brand Name : APO-TIOTROPIUM
Dosage Form : CAPSULE
Dosage Strength : 18MCG
Packaging :
Approval Date :
Application Number : 2550865
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : STRIVERDI RESPIMAT
Dosage Form : SPRAY, METERED;INHALATION
Dosage Strength : EQ 0.0025MG BASE/INH
Packaging :
Approval Date : 2014-07-31
Application Number : 203108
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Brand Name : STIOLTO RESPIMAT
Dosage Form : SPRAY, METERED;INHALATION
Dosage Strength : EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Packaging :
Approval Date : 2015-05-21
Application Number : 206756
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Sterdi Reactor
Dosage Form : Olodaterolo 2,5Mcg 30 Units - Respiratory Use
Dosage Strength : soluz inhal 30 doses 2.5 mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
TIOTROPIUM BROMIDE; Olodaterol
Brand Name : Iolto Reactor
Dosage Form : Tiotropium+Olodaterolo+2,52.5 Mcg 60 Doses Respiratory Use
Dosage Strength : soluz inhal 1 inhaler 2.5 mcg + 2.5 mcg 60 donations
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Heavy overnight value Respimat
Dosage Form : Inhalasjonsvaeske, resolution
Dosage Strength : 2.5 mcg
Packaging : Cartridge
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Olodaterol; TIOTROPIUM BROMIDE
Brand Name : Spiolto Respimat
Dosage Form : Inhalasjonsvaeske, resolution
Dosage Strength : 2.5MCG; 2.5MCG
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Tiotropium Bromide Monohydrate, Olodaterol Hydrochloride
Brand Name : Spiolto Respimat
Dosage Form : Inhalation liquid, solution
Dosage Strength : 2.5 microg/2.5 microg
Packaging : Refill for inhaler 3 60spray
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Tiotropium Bromide Monohydrate, Olodaterol Hydrochloride
Brand Name : Spiolto Respimat
Dosage Form : Inhalation liquid, solution
Dosage Strength : 2.5 microg/2.5 microg
Packaging : Inhaler with cartridge 1 60spray
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Tiotropium Bromide Monohydrate, Olodaterol Hydrochloride
Brand Name : Spiolto Respimat
Dosage Form : Inhalation liquid, solution
Dosage Strength : 2.5 microg/2.5 microg
Packaging : Inhaler with cartridge 3 60spray
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Olodaterol Hydrochloride; Tiotropium Bromide Monohydrate
Brand Name : Spiolto Respimat
Dosage Form : Solution For Inhalation
Dosage Strength : 2.5mcg/dose;2.5mcg/dose
Packaging :
Approval Date : 18/06/2015
Application Number : 20140523000034
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Olodaterol Hydrochloride; Tiotropium Bromide Monohydrate
Brand Name : Yanimo Respimat
Dosage Form : Solution For Inhalation
Dosage Strength : 2.5mcg/dose;2.5mcg/dose
Packaging :
Approval Date : 18/06/2015
Application Number : 20140523000041
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Striverdi Respimat
Dosage Form : Solution For Inhalation
Dosage Strength : 2.5mcg
Packaging :
Approval Date : 02/05/2019
Application Number : 67399
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Striverdi Respimat
Dosage Form : Solution For Inhalation
Dosage Strength : 2.5mcgperpuff
Packaging :
Approval Date : 14/11/2013
Application Number : 20120525000041
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Spiolto Respimat
Dosage Form : Solution For Inhalation
Dosage Strength : 2.5mcg;2.5mcg
Packaging :
Approval Date : 11/04/2019
Application Number : 67352
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
Brand Name : SPIRIVA
Dosage Form : CAPSULE
Dosage Strength : 18MCG
Packaging : 10/30; 1 HANDIHALER
Approval Date :
Application Number : 2246793
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
Brand Name : SPIRIVA RESPIMAT
Dosage Form : SOLUTION
Dosage Strength : 2.5MCG/ACT
Packaging : 4ML(60 PUFFS OR 28 PUFFS)
Approval Date :
Application Number : 2435381
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
Brand Name : INSPIOLTO RESPIMAT
Dosage Form : SOLUTION
Dosage Strength : 2.5MCG/ACT
Packaging : 28/60 ACT
Approval Date :
Application Number : 2441888
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OLODATEROL (OLODATEROL HYDROCHLORIDE)
Brand Name : INSPIOLTO RESPIMAT
Dosage Form : SOLUTION
Dosage Strength : 2.5MCG/ACT
Packaging : 28/60 ACT
Approval Date :
Application Number : 2441888
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
Brand Name : LUPIN-TIOTROPIUM
Dosage Form : CAPSULE
Dosage Strength : 18MCG
Packaging :
Approval Date :
Application Number : 2537850
Regulatory Info : Prescription
Registration Country : Canada