| View |
|
BR-955
|
Varicella Virus Vaccine, Live
|
Varivax
|
1350 PFU/0.5 mL
|
Lyophilized Powder For Solution
for Injection (SC)
|
Vaccine
|
Merck Sharp & Dohme Corp.
|
United States of America
|
Renewal
|
28 June 2024
|
14 July 2029
|
| View |
|
BR-957
|
Insulin Lispro (rDNA)
|
Humalog Mix25 Kwikpen
|
100 Units/mL (3.5 mg/mL) Suspension for Injection (SC) (25% Insulin Lispro Solution + 75% Insulin Lispro Protamine Suspension)
|
Suspension for Injection (SC)
|
-
|
Eli Lilly Italia S.p.A.
|
Italy
|
Initial (Variation)
|
25 October 2022
|
25 October 2027
|
| View |
|
BR-959
|
Clostridium botulinum Type A Toxin
|
Dysport
|
300 IU
|
Freeze-Dried Powder for Solution for Injection
(IM/SC)
|
-
|
IPSEN Biopharm Limited.
|
United Kingdom
|
Initial (Variation)
|
22 November 2023
|
22 November 2028
|
| View |
|
BR-961
|
Pegfilgrastim
|
Pegstim
|
6mg/ 0.6 mL
|
Solution for Injection (SC)
|
Colony Stimulating Factors
|
Cadila Healthcare Ltd.
|
India
|
Renewal
|
05 May 2024
|
18 August 2029
|
| View |
|
BR-962
|
Humulin N
|
Insulin Human (rDNA)
|
100 IU/mL
|
Suspension For Injection (SC)
|
-
|
Eli Lily and Company
|
USA
|
-
|
18 May 2021
|
20 April 2026
|
| View |
|
BR-971
|
Epoetin Alfa (Recombinant Human Erythropoietin)
|
Espogen
|
2,000 I.U./0.5 mL
|
Solution for Injection (S.C./I.V.)
|
Hematopoietic Growth Factor
|
LG Chem, Ltd.
|
Korea
|
Initial (Variation) [Correction]
|
15 March 2023
|
09 February 2028
|
| View |
|
BR-972
|
Recombinant Human Erythropoietin
|
Espogen
|
4000 IU/ 0.4 mL
|
Solution For Injection
|
Hematopoietic Growth Factor
|
LG Life Sciences Ltd.
|
Korea
|
Automatic Renewal
|
21 September 2021
|
12 September 2026
|
| View |
|
BR-975
|
Human Chorionic Gonadotropin
|
PUBERGEN
|
5000 IU
|
Lyophilized Powder for Solution for Injection (IM)
|
Gonadotrophic Hormone
|
Sanzyme (P) Limited
|
India
|
Renewal
|
13 April 2022
|
11 April 2027
|
| View |
|
BR-977
|
Recombinant Human Insulin (70% Isophane/30% Soluble)
|
Humulin 70/30
|
100 IU/mL
|
Suspension for Injection (SC)
|
Intermediate-acting Insulin
|
Eli Lilly & Company
|
U.S.A.
|
Automatic Renewal
|
17 March 2023
|
21 July 2028
|
| View |
|
BR-980
|
Insulin Human (rDNA)
|
Humulin R
|
100 IU/mL
|
Suspension for Injection (SC)
|
-
|
Eli Lilly and Company
|
U.S.A.
|
-
|
18 January 2022
|
22 May 2026
|
| View |
BR-983_PI_01.pdf
|
BR-983
|
Ustekinumab
|
Stelara
|
90 mg/mL
|
Solution for Injection (SC)
|
Interleukin Inhibitors
|
Cilag AG
|
Switzerland
|
Renewal
|
07 October 2024
|
14 October 2029
|
| View |
|
BR-986
|
Menotrophin
|
Gynogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
(IM/SC)
|
Gonadotropins
|
Sanzyme (P) Ltd.
|
India
|
Initial (from Monitored Release)
|
27 July 2022
|
11 April 2027
|
| View |
BR-990_PI_01.pdf
|
BR-990
|
Insulin Lispro
|
Humalog Mix50 Kwikpen
|
100 Units/mL (3.5 mg/mL) Suspension for Injection (SC) (50% Insulin Lispro and 50% Insulin Lispro Protamine)
|
Suspension for Injection (SC)
|
-
|
Eli Lilly Italia S.p.A.
|
Italy
|
Monitored Release (Variation)
|
28 October 2022
|
28 October 2027
|
| View |
|
BR-991
|
Urofollitropin
|
Endogen HP
|
75 IU
|
Lyophilized Powder for Solution for Injection
(IM/SC)
|
Gonadotropins
|
Sanzyme (P) Ltd.
|
India
|
Initial (from Monitored Release)
|
27 July 2022
|
11 April 2027
|
| View |
|
BR-992
|
Menotrophin
|
Menopur
|
Formulation: After reconstitution, 1 mL contains highly purified Menotrophin (human menopausal gonadotrophin, HMG) corresponding to:
Follicle Stimulating Hormone (FSH) Luteinizing Hormone (LH)
75 IU 75 IU
|
Lyophilized Powder for Solution for Injection (IM/SC)
|
Gonadotrophins
|
Ferring GmbH
|
Germany
|
Renewal
|
14 October 2020
|
24 September 2028
|
| View |
|
BRP-002
|
Hepatitis A Vaccine (Live, Attenuated)
|
Mevac-A
|
NLT 6.50 Lg CCID 50
|
Vial
|
-
|
Zhejiang Pukang Biotechnology Co. Ltd.
|
China
|
-
|
27 April 2022
|
30 March 2027
|
| View |
|
BRP-004
|
Diphtheria, Tetanus, Pertussis, Hepatitis B (rDNA) and
Haemophilus influenzae Type B Conjugate Vaccine
(Adsorbed)
|
None
|
Formulation: Each dose (0.5 mL) contains: Diptheria Toxoid.............<25 Lfl> 30 I.U.)
Tetanus Toxoid.............> 2.5 Lf> 40 I.U.) . Bordetella pertussis (whole cell)............< 16 OU (>4 1.U.) . Hepatitis B (rDNA)....................10 mcg Haemophilus influenzae congugate vaccine............ > 10 mcg
|
Suspension for Injection (IM)
|
-
|
Serum Institute of India Pvt. Ltd.
|
India
|
Renewal
|
02 June 2022
|
07 May 2027
|
| View |
|
BRP-007
|
Diphtheria, Tetanus, Pertussis, Hepatitis B And Haemophilus Influenzae Type B Conjugate Vaccine (Adsorbed)
|
None
|
Each dose (0.5 mL) contains:
Diphtheria Toxoid ≤25 Lf (≥30 IU)
Tetanus Toxoid ≥2,5 Lf (≥40 IU)
Hepatitis B (rDNA) >2.5 mcg
Bordetella pertussis (whole cell) ≤16 OU (≥4.0 IU)
Haemophilus influenzae Conjugate Vaccine10 mcg
|
Suspension for Injection (IM)
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
Renewal
|
18 September 2024
|
07 May 2029
|
| View |
|
BRP-011
|
Bemiparin sodium
|
Hibor
|
7,500IU anti-Factor Xa/0.3ml
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Renewal
|
30 June 2024
|
08 October 2029
|
| View |
|
BRP-012
|
Bemiparin sodium
|
Hibor
|
10,000IU anti-Factor Xa/0.4mL
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Renewal
|
23 June 2024
|
08 October 2029
|