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Marketing Authorisation Holder

Serum Institute of India Limited

INDIA

Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Pune, India

Maps

24

Total Medicines

24

Active

8

Dosage Forms

2

Countries

Tanzania (19) Kenya (5)

Location

Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Registration Status

Registered 24

Therapeutic Classes

GENERIC/BIOSIMILARS 4
NEW/INNOVATOR 1

Local Agents / Applicants

Serum Institute of India Limited 19
SERUM INSTITUTE OF INDIA LIMITED 5

Registered Medicines

Showing 20 of 24 · Page 1 of 2

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Product Country Status

BCG Vaccine (Freeze Dried)

Live attenuated strains of Mycobacterium bovis (Bacillus Calmette Guerin) Between 2 X 100000 and 8 X 100000 CFU/0.1 ml,Monosodium Glutamate 0.75 mg per 0.1 ml of the reconstituted product mg/ mL

Tanzania Registered/Compliant

BIVALENT POLIOMYELITIS VACCINE

MONOVALENT BULK OF POLIOMYELITIS VACCINE ;BIVALENT TYPE 1 & 3

Kenya Registered

BIVALENT POLIOMYELITIS VACCINE

MONOVALENT BULK OF POLIOMYELITIS VACCINE ;BIVALENT TYPE 1 & 3

Kenya Registered

CYVAC 1 Dose

R21 Malaria Antigen 5 mcg

Tanzania Registered/Compliant

CYVAC 2 Dose

R21 Malaria Antigen 5mcg mcg

Tanzania Registered/Compliant

DIPHTHERIA AND TETANUS VACCINE ADSORBED

1. PURIFIED DIPHTHERIA TOXOID 2. PURIFIED TETANUS TOXOID

Kenya Registered

DTPHH

Adsorbed on Aluminium Phosphate, Al+++ ≤ 1.25 mg/0.5ml,B. pertussis (whole cell) ≤ 16 OU (≥ 4 IU) IOU,Bulk Purified Tetanus Toxoid ≥ 2.5 Lf (≥ 40 IU) LF,Diphtheria Toxoid ≤ 25 Lf (≥ 30 IU) LF,Purified HBsAg ≥ 10 mcg/0.5ml,Purified capsular Hib Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg/0.5ml,Thiomersal 0.005 %

Tanzania Registered/Compliant

DTPHH Vaccine

Adsorbed on Aluminium Phosphate, Al+++ ≤ 1.25 mg/0.5ml,B. pertussis (whole cell) ≤ 16 OU (≥ 4 IU) IOU,Diphtheria Toxoid ≤ 25 Lf (≥ 30 IU) LF,Purified HBsAg ≥ 10 mcg/0.5ml,Purified Tetanus Toxoid ≥ 2.5 Lf (≥ 40 IU) Lf/0.5ml,Purified capsular Hib Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg/0.5ml,Thiomersal 0.005 %

Tanzania Registered/Compliant

Hepatitis B Vaccine (rDNA) (Paediatric)

Aluminium hydroxide gel. 0.25 mg to 0.40 mg mg,Purified Hepatitis B surface antigen(HBsAg) 10 mcg/0.5ml,Thiomersal (as preservative) 0.005 %

Tanzania Registered/Compliant

Hepatitis B Vaccine r-DNA, Adult

Hepatitis B Surface Antigen Aqueous 20 mcg/ml

Tanzania Registered/Compliant

Hepatitis B Vaccine r-DNA, Paediatric

Hepatitis B Surface Antigen Aqueous 10 mcg/ml

Tanzania Registered/Compliant

Measles & Rubella Vaccine Live, Attenuated (Freeze dried)

L - Arginine Hydrochloride 1.60 %,L histidine 0.21 %,L-Alanine 0.1 %,Lactalbumin hydrolysate 0.35 %,Measles Virus 1000 CCID50/dose,Minimum Essensial Medium (MEM) QS QS,Partially hydrolysed gelatin 2.5 %,Rubella Virus 1000 CCID50/dose,Sorbitol 5 %,Tricine 0.3 %

Tanzania Registered/Compliant

Measles & Rubella Virus Vaccine Live U.S.P 10 doses

Anhydrous Disodium hydrogen Phosphate g/g,Disodium Edetate g/g,L - Arginine Hydrochloride g/g,Lactalbumin hydrolysate g/g,Measles Virus mg/4ml,Measles Virus 1x10000 mg/4ml,Minimum Essensial Medium (MEM) g/g,Mumps Virus 12.5 x 10000 mg/4ml,Rubella Virus mg/4ml,Rubella Virus 1 x 10000 mg/4ml,Tricine g/g

Tanzania Registered/Compliant

Measles Mumps and Rubella Vaccine Live, Attenuated (Freeze-Dried) 1 dose

L - Arginine Hydrochloride 1.60 %,L-Alanine 0.1 %,L-Histidine 0.21 %,Lactalbumin hydrolysate 0.35 %,Measles Virus 1000 CCID50/0.5ml,Minimum Essensial Medium (MEM) QS QS,Mumps Virus 5000 CCID50/0.5ml,Partially hydrolysed gelatin 2.5 %,Rubella Virus 1000 CCID50/0.5ml,Sorbitol 5 %,Tricine 0.3 %

Tanzania Registered/Compliant

Pneumococcal Polysaccharide 10 Valent Conjugate Vaccine (adsorbeb) (10-Valent) 1 dose

Conjugated to CRM197carrier protein Aluminium (as Aluminium phospahe) 0.125 mg,Saccharide serotype 14 2 mcg,Saccharide serotype 19A 2 mcg,Saccharide serotype 19F 2 mcg,Saccharide serotype 23F 2 mcg,Saccharide serotype 7F 2 mcg,Saccharide serotype 9V 2 mcg,Saccharides for serotype 6B 4 mcg,Saccharides serotypes 1, 5, 9V, 14,19A, 19F, 23F, 7F, 6A 2 mcg,Thiomersal 0.005 %

Tanzania Registered/Compliant

Pneumococcal Polysaccharide Conjugate Vaccine(adsorbed) (10 Valent) 5 dose

Saccharide serotype 1 2 mcg,Saccharide serotype 14 2 mcg,Saccharide serotype 19A 2 mcg,Saccharide serotype 19F 2 mcg,Saccharide serotype 23F 2 mcg,Saccharide serotype 5 2 mcg,Saccharide serotype 6A 2 mcg,Saccharide serotype 6B 4 mcg,Saccharide serotype 7F 2 mcg,Saccharide serotype 9V 2 mcg

Tanzania Registered/Compliant

RABIVAX -S

Purified Rabies Antigen (Rabies virus Pitman-Moore Strain 3218-VERO adapted and grown on vero cells, inactivated by using β - propiolactone) 2.5 IU/ml

Tanzania Registered/Compliant

REPOITIN 4000

Erythropoietin concentrated solution 4000 IU/0.4

Tanzania Registered/Compliant

REPOITIN 4000 (PFS)

EPOETIN ALFA

Kenya Registered

REPOITIN 4000/1ML (VIAL)

EPOETIN ALFA

Kenya Registered
24 products