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

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Product	Form / Strength	Country	Reg. Number	Status
ADSORBED TETANUS VACCINE B.P TETANUS TOXOID 1 DOSE Tetanus Toxoid, Each single 0.5 ml human dose contains: Tetanus Toxoid ?5 Lf (? 40 IU) Adsorbed onto Aluminium Phosphate, Al3+? 1.25 mg 0.5ml/1 dose	Suspension for Injection ? 40 IU, +? 1.25 mg 0.5ml/1 dose	Rwanda	Rwanda FDA-HBP-MA-0103	Registered
ADSORBED TETANUS VACCINE B.P TETANUS TOXOID VACCINE ADSORBED TETANUS VACCINE	SUSPENSION FOR INJECTION. USED IN THE PREVENTION OF TETANUS IN INFANTS ,CHILDREN AND ADULTS LIABLE TO BE EXPOSED TO TETANUS INFECTION AND PERSONS ENGAGED IN OUTDOOR ACTIVITIES 10 DOSE	Ghana	FDA/HVC/243-02007	Valid
BCG VACCINE TUBERCULOSIS VACCINE (FREEZE-DRIED) LYOPHILIZED	LYOPHILIZED INJECTION. GIVEN ROUTINELY TO ALL INFANTS AT RISK OF EARLY EXPOSURE TO TUBERCULOSIS 10 & 20 DOSE	Ghana	FDA/HVC/243-02006	Valid
BCG VACCINE (FREEZE-DRIED) LIVE ATTENUATED STRAINS OF MYCOBACTERIUM BOVIS	LYOPHILIZED INJECTION 2 X 105 AND 8 X 105 C.F.U.	Rwanda	Rwanda FDA-HBP-MA-003	Registered
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	live, freeze-dried vaccine	Tanzania	TAN 23 V 0122	Registered/Compliant
CYVAC R21 Malaria Vaccine (Recombinant, Adjuvanted)	Solution for Injection 5mcg per 0.5mL	Rwanda	Rwanda FDA-HBP-MA-0142	Registered
CYVAC R21 MALARIA ANTIGEN	SOLUTION; INJECTION 5 MCG/0.5ML	Zimbabwe	2024/18.2/6711	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
CYVAC R21 MALARIA ANTIGEN	SOLUTION; INJECTION 5 MG/0.5ML	Zimbabwe	2024/18.2/6710	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
CYVAC (R21 Malaria Vaccine) R21 Malaria Antigen 0.5 mcg per 0.5 mL mcg	Solution for injection 0.5 mcg per 0.5 mL mcg	Zambia	ZAMRA-HM-24-28	Registered/Compliant
CYVAC 1 Dose R21 Malaria Antigen 5 mcg	Solution for injection	Tanzania	TAN 24 V 0131	Registered/Compliant
CYVAC 2 Dose R21 Malaria Antigen 5mcg mcg	Solution for injection	Tanzania	TAN 24 V 0132	Registered/Compliant
DIPHTERIA,TETANUS,HEPATITIS B AND HAEMOPHILUS INFLUENZA TYPE B CONJUGATE VACCINE ADSORBED DIPHTERIA,TETANUS,HEPATITIS B AND HAEMOPHILUS INFLUENZA TYPE B CONJUGATE VACCINE ADSORBED	SUSPENSION FOR INJECTION 0.5ML/DOSE	Ghana	FDA/HVC/243-01001	3 months to expiry
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 %	Suspension for injection	Tanzania	TZ13H210	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 %	Suspension for injection	Tanzania	TZ13H211	Registered/Compliant
Diptheria-Tetanus-Pertusis Vaccine Adsorbed injection 10 Doses Diptheria+ Pertusis+ Tetanus toxoids	Suspension for Injection	Zambia	053/011	Registered/Compliant
HEPATITIS B VACCINE (PAEDIATRIC ) HEPATITIS B VACCINE (rDNA)	HEPATITIS B VACCINE (rDNA) 10MCG	Ghana	FDA/HVC/245-12024	Valid
HEPATITIS B VACCINE (RDNA) (ADULT) -	SUSPENSION FOR INJECTION	Botswana	BOT2203866	Registered/Compliant
HEPATITIS B VACCINE (rDNA) (ADULT) 1 DOSE Hepatitis B Surface Antigen (Aqueous), 20mcg/1ml	Suspension for injection 20mcg/1ml	Rwanda	Rwanda FDA-HBP-MA-0111	Registered
Hepatitis B Vaccine (rDNA) (Adult) Purified Hepatitis- B surface antigen (produced in Hansenula polymorpha yeast) 20 mcg	Suspension for Injection 20 mcg	Zambia	053/003	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 %	Suspension for injection	Tanzania	TAN 24 V 0039	Registered/Compliant

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