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01 1Apotex Inc

02 27Boehringer Ingelheim GmbH

03 1Lupin Ltd

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

OLODATEROL HYDROCHLORIDE

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

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol

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

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol

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

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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10

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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11

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

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12

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol

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

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13

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol Hydrochloride

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

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14

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Tiotropium; Olodaterol

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

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15

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol Hydrochloride; Tiotropium Bromide; Monohydrate

Brand Name : Spiolto Respimat

Dosage Form : Solution

Dosage Strength : 2.5MCG; 2.5 MCG

Packaging :

Approval Date : 2019-11-21

Application Number : 34009 300 413 2 1

Regulatory Info : Authorized

Registration Country : Spain

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16

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol Hydrochloride; Tiotropium Bromide; Monohydrate

Brand Name : Spiolto Respimat

Dosage Form : Solution For Inhalation

Dosage Strength : 2.5MCG; 2.5 MCG

Packaging :

Approval Date : 2015-06-26

Application Number : 79967

Regulatory Info : Authorized

Registration Country : Spain

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17

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol Hydrochloride

Brand Name : Striverdi Respimat

Dosage Form : Solution For Inhalation

Dosage Strength : 2.5MCG

Packaging :

Approval Date : 2013-12-03

Application Number : 78253

Regulatory Info : Authorized

Registration Country : Spain

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18

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Tiotropium; Olodaterol

Brand Name : Yanimo Respimat

Dosage Form : Solution

Dosage Strength : 2.5MCG; 2.5 MCG

Packaging :

Approval Date : 2015-06-26

Application Number : 79966

Regulatory Info : Authorized

Registration Country : Spain

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19

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol

Brand Name : Striverdi Respimat

Dosage Form : Solution For Inhlation

Dosage Strength : 2.5MCG

Packaging :

Approval Date : 2013-09-18

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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20

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Olodaterol; Tiotropium Bromide

Brand Name : Yanimo Respimat

Dosage Form : Solution For Inhlation

Dosage Strength : 2.5MCG; 2.5MCG

Packaging :

Approval Date : 2015-06-30

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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