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01 2Sanofi

02 2Biomed Lublin

03 1Central Procurement & Supplies Unit

04 3Cherubino Limited

05 11GSK

06 2Grifols International

07 1JV Healthcare Limited

08 1KI Biopharma

09 2LG Life Sciences

10 2Labomed Ltd

11 6Merck & Co

12 3NM Pharma Limited

13 1National Bioproducts Institute

14 2The Biovac Institute

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Originator

Registration Country : South Africa

Hepatitis B surface antigen

Brand Name : Hexaxim ®

Dosage Form : INJ

Dosage Strength : 10µg/0.5ml

Packaging : 0.5X1IU/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Originator

Registration Country : South Africa

Hepatitis B surface antigen

Brand Name : Hexaxim ®

Dosage Form : INJ

Dosage Strength : 10µg/0.5ml

Packaging : 0.5X10IU/0.5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Immune Globulin

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

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Immune Globulin

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

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen, Recombinant

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 10MCG

Packaging :

Approval Date : 2006-10-31

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen, Recombinant

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2006-10-31

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen, Recombinant

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG/L

Packaging :

Approval Date : 2006-10-31

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Fendrix, Injectable Suspension

Dosage Form : Injectable Suspension

Dosage Strength :

Packaging :

Approval Date : 23-02-2005

Application Number : 4299003

Regulatory Info : Authorized

Registration Country : Spain

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Euvax B Adult

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2014-07-10

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Euvax B Pediatric

Dosage Form : Suspension For Injection

Dosage Strength : 10MCG

Packaging :

Approval Date : 2014-07-10

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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11

Cherubino Limited

Country
ASPEN
Not Confirmed
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Cherubino Limited

Country
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ASPEN
Not Confirmed

Aluminium Hydroxide; Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Euvax B

Dosage Form : Suspension For Injection

Dosage Strength : 0.25MG; 10MCG

Packaging :

Approval Date : 2015-08-04

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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12

Cherubino Limited

Country
ASPEN
Not Confirmed
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Cherubino Limited

Country
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ASPEN
Not Confirmed

Aluminium Hydroxide; Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Euvax B

Dosage Form : Suspension For Injection

Dosage Strength : 0.5MG; 20MCG

Packaging :

Approval Date : 2015-08-04

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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13

Central Procurement & Supplies Unit

Country
ASPEN
Not Confirmed
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Central Procurement & Supplies Unit

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2019-04-11

Application Number :

Regulatory Info : Invalid

Registration Country : Malta

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14

Labomed Ltd

Country
ASPEN
Not Confirmed
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Labomed Ltd

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 10MCG

Packaging :

Approval Date : 2019-10-28

Application Number :

Regulatory Info : Invalid

Registration Country : Malta

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15

NM Pharma Limited

Country
ASPEN
Not Confirmed
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NM Pharma Limited

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG/ML

Packaging :

Approval Date : 2021-10-15

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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16

JV Healthcare Limited

Country
ASPEN
Not Confirmed
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JV Healthcare Limited

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2023-10-20

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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17

Cherubino Limited

Country
ASPEN
Not Confirmed
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Cherubino Limited

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Hbs Ag)

Brand Name : Euvax B,

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2024-12-09

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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18

Labomed Ltd

Country
ASPEN
Not Confirmed
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Labomed Ltd

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Rdna)

Brand Name : Engerix B. In Pre-Filled Syringe Hepatitis B (Rdna) Vaccine Adsorbed (Hbv)

Dosage Form : Suspension For Injection

Dosage Strength : 5ML

Packaging :

Approval Date : 2020-04-01

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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19

NM Pharma Limited

Country
ASPEN
Not Confirmed
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NM Pharma Limited

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Rdna)

Brand Name : Engerix-B

Dosage Form : Suspension For Injection

Dosage Strength : 20MCG

Packaging :

Approval Date : 2020-12-17

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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20

NM Pharma Limited

Country
ASPEN
Not Confirmed
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NM Pharma Limited

Country
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ASPEN
Not Confirmed

Hepatitis B Surface Antigen (Rdna)

Brand Name : Engerix B

Dosage Form : Suspension For Injection

Dosage Strength : 10MCG

Packaging :

Approval Date : 2021-01-07

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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