Marketing Authorisation Holder

Serum Institute Of India

INDIA

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

Pune, India

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Total Medicines

Active

Dosage Forms

Countries

Tanzania (19) Rwanda (17) Ghana (16) Zimbabwe (12) Zambia (11) Botswana (5)

Location

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

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Registration Status

Registered 52

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 12

Valid 11

3 months to expiry 5

Dosage Forms

Suspension for injection 10 VACCINE 9 Solution for injection 7 Suspension for Injection 6 INJECTION 5 Live freeze-dried vaccine 4 Injection 3 Suspension of injection 2

Local Agents / Applicants

Serum Institute of India Limited 19

SERUM INSTITUTE OF INDIA PVT LTD 12

Serum Institute of India... 11

Serum Institute of India Pvt. Ltd. 6

SERUM INSTITUTE OF INDIA PVT. LTD 6

M & G PHARMACEUTICALS... 6

Registered Medicines

Showing 20 of 80 · Page 2 of 4

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Product	Form / Strength	Country	Reg. Number	Status
Hepatitis B Vaccine (rDNA) (Paediatric) 10 mcg of purified Hepatitis B surface Antigen (Produced in Hansenula polymorpha yeast)	Injection -	Rwanda	RWANDA-FDA25/HM/0166/0071	Registered
Hepatitis B Vaccine r-DNA, Adult Hepatitis B Surface Antigen Aqueous 20 mcg/ml	Suspension for injection 20	Tanzania	TAN 05,684 J07A SER	Registered/Compliant
Hepatitis B Vaccine r-DNA, Paediatric Hepatitis B Surface Antigen Aqueous 10 mcg/ml	Suspension for injection	Tanzania	TAN 05,682 J07A SER	Registered/Compliant
Hexasiil Diphtheria 30IU, Tetanus 40IU, Pertussis 4IU, Hepatitis B 15mcg, Polio type 1, 2, 3 (40 DU, 8 DU, 32 DU), Haemophilus influ b 10mcg, Conj. V 19-33mcg	Suspension of injection -	Rwanda	RWANDA-FDA25/HM/0244/0062	Registered
MEASLES AND RUBELLA VACCINE (LIVE) (ATTENUATED, FREEZE DRIED) MEASLES VIRUS AND RUBELLA VIRUS	INJECTION 1000 CCID50 & 1000 CCID50	Rwanda	Rwanda FDA-HBP-MA-0145	Registered
MEASLES AND RUBELLA VACCINE LIVE ATTENUATED MEASLES AND RUBELLA VACCINE LIVE ATTENUATED	MEASLES AND RUBELLA VACCINE LIVE ATTENUATED 0.5ML/DOSE	Ghana	FDA/HVC/233-07012	3 months to expiry
MEASLES AND RUBELLA VACCINE LIVE, ATTENUATED, (FREEZE DRIED) LIVE ATTENUATED MEASLES AND RUBELLA VACCINE	FOR ACTIVE IMMUNIZATION AGAINST MEASLES AND RUBELLA 10 DOSE	Ghana	FDA/HVC/243-02005	3 months to expiry
MEASLES VACCINE 10 DOSE MEASLES VACCINE, LIVE ATTENUATED	MEASLES VACCINE, LIVE ATTENUATED NOT LESS THAN 1000 CCID50 OF MEASLES VIRUS	Ghana	FDA/HVC/245-10018	Valid
MEASLES VACCINE, LIVE ATTENUATED (FREEZE-DRIED) CLARIFIED VIRUS POOL OF MEASLES VIRUS	LYOPHILIZED INJECTION 1000 CCID50 OF MEASLES VIRUS/ 0.5ML.	Rwanda	Rwanda FDA-HBP-MA-004	Registered
MENFIVE (MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE VACCINE (FREEZE-DRIED) 1 DOSE WITH DILUENT MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE	MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE 0.5ML	Ghana	FDA/HVC/243-06012	Valid
MENFIVE (MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE VACCINE (FREEZE-DRIED) 5 DOSE WITH DILUENT MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE	MENINGOCOCCAL A,C,Y,W,X) POLYSACCHARIDE CONJUGATE 2.5ML	Ghana	FDA/HVC/243-06013	Valid
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 %	Injection	Tanzania	TZ14H019	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	Injection	Tanzania	TZ14H019	Registered/Compliant
Measles Mumps & Rubella Vaccine Live Attenuated (Freeze Dried) Measles + Rubella 1000 CCID50% per dose,Mumps Virus 5000 CCID50% per dose	Live freeze-dried vaccine 1000 CCID50% per dose,5000 CCID50% per dose	Zambia	053/006	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 %	Lyophilized Injection	Tanzania	TZ14H012	Registered/Compliant
Measles Vaccine+ Live+ Attenuated (Freeze Dried) injection Measles Virus 1000 CCID50% per dose	Live freeze-dried vaccine 1000 CCID50% per dose	Zambia	053/005	Registered/Compliant
Measles and Rubella Vaccine Live, Attenuated (Free-Dried) L-Alanine 0.1% Measles Virus Vaccine Live Attenuated 1000 CCID 50/dose Rubella Vaccine 1000 CCID50/dose 10 doses	Live freeze-dried vaccine 10 doses	Zambia	053/012	Registered/Compliant
Measles and Rubella Vaccine Live, Attenuated (Freeze-Dried) L-Alanine 0.1% Measles Virus Vaccine Live Attenuated 1000 CCID 50/dose Rubella Vaccine 1000 CCID50/dose 10 doses	Live freeze-dried vaccine 10 doses	Zambia	053/012	Registered/Compliant
MenFive Meningococcal (A,C,Y,W,X) Polysaccharide Conjugate Vaccine (Freeze-Dried)	Lyophilised powder for injection	Zambia	ZAMRA-HM-26-60	Registered/Compliant
MenFive [Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried)] -	Lyophilized powder for injection 1 Dose, 5 Dose	Rwanda	Rwanda FDA-HMP-MA-2346	Registered

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