Aclidinium bromide (JAN/USAN/INN) | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Aclidinium Bromide (JAN/USAN/INN)
Europe

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Aclidinium bromide (JAN/USAN/INN)

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 4 USDMF, 1 JDMF, 1 EU WC, 1 KDMF, 2 NDC API, 10 Listed Suppliers, $ API Reference Price

13 API Suppliers
4 USDMF
1 JDMF
1 EU WC
1 KDMF
2 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 2 FDA Orange Book, 21 Europe, 2 Canada, 4 Australia

29 FDF Dossiers
2 FDA Orange Book
21 Europe
2 Canada
4 Australia

DRUG PRODUCT COMPOSITIONS

POWDER, METERED;INHALATION - 0.4MG/INH, POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH

POWDER, METERED;INHALATION - 0.4MG/INH
POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH

RELATED EXCIPIENT COMPANIES

2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 DFE Pharma, 9 Kerry, 2 Microlex e.U, 1 Pluviaendo, 1 Sigachi Industries

2 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
2 DFE Pharma
9 Kerry
2 Microlex e.U
1 Pluviaendo
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

9 Fillers, Diluents & Binders, 7 Granulation, 5 Direct Compression, 2 Co-Processed Excipients, 1 Parenteral

9 Fillers, Diluents & Binders
7 Granulation
5 Direct Compression
2 Co-Processed Excipients
1 Parenteral

DIGITAL CONTENT

10 News #PharmaBuzz

10 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 10 Annual Reports

2 US Medicaid Prescriptions
4 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

4 US Patents, 7 Health Canada Patents

4 US Patents
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP

1 USP

$ API Ref.Price (USD/KG) : 954 Xls

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21 All

01 4ASTRAZENECA AB

02 4Covis Pharma Europe BV

03 12Covis Pharma Europe Bv

04 1Covis Pharma Gmbh

filter Active Ingredients Reset all filters

21 All

01 1Aclidinium

02 5Aclidinium Bromide

03 2Aclidinium Bromide; Formoterol

04 2Aclidinium Bromide; Formoterol Fumarate Dihydrate

05 2Aclidinium Bromide; Formoterol fumarate dihydrate

06 5Aclidinium bromide

07 2Formoterol Fumarate Dihydrate; Aclidinium Bromide

08 2Formoterol; Aclidinium bromide

filter Dosage Form Reset all filters

21 All

01 2Aclidinio Bromide 322Mcg 60 Doses Respiratory Use

02 2Aclidinio+Formoterol+34012 Mcg 60 Doses Respiratory Use

03 13Inhalation Powder

04 4Powder For Inhalation

filter Country Reset all filters

21 All

01 4Italy

02 5Moldova

03 4Norway

04 3Spain

05 4Sweden

06 1Switzerland

filter Brand Name Reset all filters

21 All

01 2Bretaris Genuair

02 3Bretaris® Genuair®

03 1Brice Genuair

04 2Brimica Genuair

05 2Brimica® Genuair®

06 5Duaklir Genuair

07 6Eklira Genuair

Inke Aclidinium Bromide

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Product Main Page

01

ASTRAZENECA AB

VMX

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ASTRAZENECA AB

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Regulatory Info :

Registration Country : Italy

Aclidinium Bromide

Brand Name : Bretaris Genuair

Dosage Form : Aclidinio Bromide 322Mcg 60 Doses Respiratory Use

Dosage Strength : 1 bottle 60 doses groun inhal 322 mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

ASTRAZENECA AB

VMX

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ASTRAZENECA AB

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Regulatory Info :

Registration Country : Italy

Aclidinium Bromide

Brand Name : Eklira Genuair

Dosage Form : Aclidinio Bromide 322Mcg 60 Doses Respiratory Use

Dosage Strength : 1 inhaler 60 doses groun inhal 322 mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

ASTRAZENECA AB

VMX

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ASTRAZENECA AB

VMX

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Regulatory Info :

Registration Country : Italy

Aclidinium Bromide; Formoterol

Brand Name : Brice Genuair

Dosage Form : Aclidinio+Formoterol+34012 Mcg 60 Doses Respiratory Use

Dosage Strength : 1 inhaler 60 doses groun inhal 340 mcg + 12 mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ASTRAZENECA AB

VMX

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ASTRAZENECA AB

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Regulatory Info :

Registration Country : Italy

Aclidinium Bromide; Formoterol

Brand Name : Duaklir Genuair

Dosage Form : Aclidinio+Formoterol+34012 Mcg 60 Doses Respiratory Use

Dosage Strength : 1 inhaler 60 doses groun inhal 340 mcg + 12 mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

Covis Pharma Gmbh

VMX

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Covis Pharma Gmbh

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Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Eklira Genuair

Dosage Form : Powder For Inhalation

Dosage Strength : 375mcg

Packaging :

Approval Date : 2013-04-25

Application Number : 62590

Regulatory Info : Allowed

Registration Country : Switzerland

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06

Covis Pharma Europe Bv

VMX

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Covis Pharma Europe Bv

VMX

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Regulatory Info : Approved

Registration Country : Sweden

Aclidinium Bromide

Brand Name : Bretaris Genuair

Dosage Form : Inhalation Powder

Dosage Strength : 322mcg

Packaging :

Approval Date : 2012-07-20

Application Number : 20120218000051

Regulatory Info : Approved

Registration Country : Sweden

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07

Covis Pharma Europe Bv

VMX

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Covis Pharma Europe Bv

VMX

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Regulatory Info : Approved

Registration Country : Sweden

Aclidinium Bromide

Brand Name : Eklira Genuair

Dosage Form : Inhalation Powder

Dosage Strength : 322mcg

Packaging :

Approval Date : 2012-07-20

Application Number : 20110824000057

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

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08

Covis Pharma Europe Bv

VMX

Not Confirmed

Covis Pharma Europe Bv

VMX

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Regulatory Info : Approved

Registration Country : Sweden

Aclidinium Bromide; Formoterol Fumarate Dihydrate

Brand Name : Brimica Genuair

Dosage Form : Inhalation Powder

Dosage Strength : 340mcg;12mcg

Packaging :

Approval Date : 2014-11-19

Application Number : 20140321000076

Regulatory Info : Approved

Registration Country : Sweden

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09

Covis Pharma Europe Bv

VMX

Not Confirmed

Covis Pharma Europe Bv

VMX

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Regulatory Info : Approved

Registration Country : Sweden

Aclidinium Bromide; Formoterol Fumarate Dihydrate

Brand Name : Duaklir Genuair

Dosage Form : Inhalation Powder

Dosage Strength : 340mcg;12mcg

Packaging :

Approval Date : 2014-11-19

Application Number : 20131123000012

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

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10

Covis Pharma Europe Bv

VMX

Not Confirmed

Covis Pharma Europe Bv

VMX

Not Confirmed

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Regulatory Info : Authorized

Registration Country : Spain

Formoterol Fumarate Dihydrate; Aclidinium Bromide

Brand Name : Duaklir Genuair

Dosage Form : Powder For Inhalation

Dosage Strength : 340MCG; 12 MCG

Packaging :

Approval Date : 2015-02-13

Application Number : 114964001

Regulatory Info : Authorized

Registration Country : Spain

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