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01 2Biomed Lublin
02 6GSK
03 2Grifols International
04 1KI Biopharma
05 6Merck & Co
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01 8Injectable Suspension
02 4Injectable Suspension In Pre-Filled Syringe
03 3SOLUTION
04 2Solution for Injection
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01 10Authorized
02 2Cancelled
03 3Schedule D
04 2Blank
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01 2Engerix- B
02 2Engerix- B Junior
03 2Fendrix, Injectable Suspension
04 1GAMMA anty-HBs 1000
05 1GAMMA anty-HBs 200
06 1HEPAGAM B
07 2HYPERHEP B
08 6Hbvaxpro
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01 3Canada
02 2Poland
03 12Spain
Regulatory Info :
Registration Country : Poland
Brand Name : GAMMA anty-HBs 200
Dosage Form : Solution for Injection
Dosage Strength : 200IU
Packaging : 1 ampoule 1.0 ml cardboard box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Poland
Regulatory Info :
Registration Country : Poland
Brand Name : GAMMA anty-HBs 1000
Dosage Form : Solution for Injection
Dosage Strength : 1000IU
Packaging : 1 ampoule 1.5 ml cardboard box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Poland
Regulatory Info : Schedule D
Registration Country : Canada
HEPATITIS B IMMUNOGLOBULIN (HUMAN)
Brand Name : HYPERHEP B
Dosage Form : SOLUTION
Dosage Strength : 220UNIT/ML
Packaging :
Approval Date :
Application Number : 2520001
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
HEPATITIS B IMMUNOGLOBULIN (HUMAN)
Brand Name : HYPERHEP B
Dosage Form : SOLUTION
Dosage Strength : 110UNIT/0.5ML
Packaging :
Approval Date :
Application Number : 2520125
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Fendrix, Injectable Suspension
Dosage Form : Injectable Suspension
Dosage Strength :
Packaging :
Approval Date : 2005-02-23
Application Number : 04299003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Engerix- B Junior
Dosage Form : Injectable Suspension
Dosage Strength : 10MCG
Packaging :
Approval Date : 1990-06-01
Application Number : 58866
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Engerix- B
Dosage Form : Injectable Suspension
Dosage Strength : 20MCG
Packaging :
Approval Date : 1987-10-01
Application Number : 57513
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Engerix- B
Dosage Form : Injectable Suspension In Pre-Filled Syringe
Dosage Strength : 20MCG
Packaging :
Approval Date : 1995-11-01
Application Number : 60653
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Engerix- B Junior
Dosage Form : Injectable Suspension In Pre-Filled Syringe
Dosage Strength : 10MCG
Packaging :
Approval Date : 1995-11-01
Application Number : 60652
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Fendrix, Injectable Suspension
Dosage Form : Injectable Suspension
Dosage Strength :
Packaging :
Approval Date : 2005-02-23
Application Number : 04299001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Schedule D
Registration Country : Canada
HEPATITIS B IMMUNOGLOBULIN (HUMAN)
Brand Name : HEPAGAM B
Dosage Form : SOLUTION
Dosage Strength : 312UNIT/ML
Packaging :
Approval Date :
Application Number : 2290979
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension
Dosage Strength : 10MCG
Packaging :
Approval Date : 2001-05-22
Application Number : 01183007
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension
Dosage Strength : 5MCG
Packaging :
Approval Date : 2001-12-12
Application Number : 01183018
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension
Dosage Strength : 40MCG
Packaging :
Approval Date : 2001-05-22
Application Number : 01183015
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension In Pre-Filled Syringe
Dosage Strength : 10MCG
Packaging :
Approval Date : 2005-09-22
Application Number : 01183028
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension In Pre-Filled Syringe
Dosage Strength : 5MCG
Packaging :
Approval Date : 2005-09-22
Application Number : 01183024
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hbvaxpro
Dosage Form : Injectable Suspension
Dosage Strength : 5MCG
Packaging :
Approval Date : 2001-01-22
Application Number : 01183001
Regulatory Info : Authorized
Registration Country : Spain