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Marketing Authorisation Holder

GlaxoSmithKline Biologicals SA

BELGIUM

Rue de l'Institut 89, 1330 Rixensart, Belgium

Rixensart, Belgium

Maps

8

Total Medicines

8

Active

4

Dosage Forms

1

Country

Tanzania (8)

Location

Rue de l'Institut 89, 1330 Rixensart, Belgium

Registration Status

Registered 8

Local Agents / Applicants

GSK Biologicals SA 7
Pfizer Laboratories Limited 1

Distributing Wholesalers

Licensed wholesalers / distributors that carry this MAH's brands.

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Registered Medicines

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Product Country Status

Cervarix Vaccine

3 - O - deacyl- 4- monophosphoryl lipid A 50 mcg/ml,Aluminium Hydroxide 0.5 mg,Human Papillomavirus type 16 L1 Protein 20 µg/0.5 ml,Human Papillomavirus type 18 L1 Protein 20 µg/0.5 ml

Tanzania Registered/Compliant

Engerix B

Hepatitis B Vaccine 10 mcg/0.5ml

Tanzania Registered/Compliant

Engerix B

Hepatitis B Vaccine 20 mcg/0.5ml

Tanzania Registered/Compliant

Engerix B Paediatric

Hepatitis B Vaccine 10 mcg/0.5ml

Tanzania Registered/Compliant

Nimenrix vaccine

1conjugated to tetanus toxoid carrier protein 44 mcg/ml,Neisseria meningitidis group A polysaccharide1 5 mcg/ml,Neisseria meningitidis group C polysaccharide1 5 mcg/ml,Neisseria meningitidis group W-135 polysaccharide1 5 mcg/ml,Neisseria meningitidis group Y polysaccharide1 5 mcg/ml

Tanzania Registered/Compliant

Polio Sabin One and Three (Oral)

Virus Polio Type 1, strain LSc, 2ab > 10(6.0) CCID50/0.1ml,Virus Polio Type 3, strain Leon 12a > 10(5.8) CCID50/0.1ml

Tanzania Registered/Compliant

Rotarix

Di-sodium adipate 132.74 mg mg/ 1.5 ml,Dulbecco’s Modified Eagle’s Medium (DMEM) 2.26 mg mg/ 1.5 ml,Live attenuated Human Rotavirus RIX4414 Strain not less than 10^6.0 CCID50/dose,Sucrose 1.073g gram,Water for Injection q.s. ad 1.5ml ml

Tanzania Registered/Compliant

Rotarix Oral Suspension Vaccine

Human Rotavirus Live Attenuated R1X4414 Strain CCLD50 Not Less than 10000000 CCID50/dose

Tanzania Registered/Compliant