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01 3Orion Corporation
02 2ALFRED E TIEFENBACHER GmbH & Co KG
03 3Farm Agon
04 3G.L. Pharma Gmbh
05 3Glenmark Arzneimittel Gmbh
06 4Kern Pharma Sl
07 4Neuraxpharm Spain Sl
08 3Newbury Pharmaceuticals Ab
09 4Normon Laboratories Sa
10 3PFIZER ITALIA Srl
11 14Pfizer Europe Ma Eeig
12 5Pfizer Limited
13 3Pfizer Ltd, Kent
14 3Stada Pharmaceuticals Ag
15 7Teva Bv
16 3Zentiva Ks
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01 27Varenicline
02 11Varenicline Citrate
03 29Varenicline Tartrate
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01 4Antic-calc Tablet, Film Coated
02 45Film Coated Tablet
03 13Tablet
04 5Blank
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01 2Germany
02 3Italy
03 6Norway
04 35Spain
05 21Sweden
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01 4Byteqi
02 28Champix
03 3Civarenix
04 3Cuitvar
05 4Vareniclina Kern Pharma
06 4Vareniclina Teva
07 3Varenicline Glenmark
08 3Varenicline Newbury
09 4Varenicline Normon
10 3Varenicline Orion
11 3Varenicline Stada
12 3Varenicline Zentiva
13 2Blank
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Varenicline Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5mg
Packaging :
Approval Date : 30/06/2025
Application Number : 20240402000169
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Varenicline Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5mg;1mg
Packaging :
Approval Date : 30/06/2025
Application Number : 20240402000183
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Varenicline Orion
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date : 30/06/2025
Application Number : 20240402000176
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info :
Registration Country : Italy
Brand Name : Champix
Dosage Form :
Dosage Strength : 28 Cpr Riv 1 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Champix
Dosage Form :
Dosage Strength : 56 Cpr Riv 1 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Champix
Dosage Form :
Dosage Strength : 11 Cpr 0.5 Mg + 14 Cpr 1 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Champix
Dosage Form :
Dosage Strength :
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Champix
Dosage Form :
Dosage Strength :
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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