| 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 |
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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 |
|
BR-993
|
Insulin human (rDNA)
|
Mixtard 30
|
100 IU/mL (70% Isophane + 30% Soluble Insulin Human)
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
-
|
09 June 2021
|
11 November 2024
|
| View |
|
BR-995
|
Insulin Human (rDNA)
|
Insulyf-R (Regular)
|
100 IU/mL
|
Solution For Injection (Sc)
|
Insulins and Analogues
|
Biocon Limited
|
India
|
Automatic Renewal
|
14 October 2021
|
05 November 2026
|
| View |
|
BR-996
|
Isophane Insulin
|
Insulyf-N (Nph)
|
100 IU/mL
|
Suspension For Injection (Sc)
|
Insulins and Analogues
|
Biocon Limited
|
India
|
Renewal
|
22 October 2021
|
05 November 2026
|
| View |
|
BR-997
|
Insulin Human (rDNA)
|
Insulyf-30/70 (Biphasic)
|
100 IU/mL
|
Suspension For Injection (Sc)
|
Insulins and Analogues
|
Biocon Limited
|
India
|
Automatic Renewal
|
01 October 2021
|
05 November 2026
|
| View |
BR-999_PI_01.pdf
|
BR-999
|
Insulin Degludec
|
Tresiba Flextouch
|
100 Units/mL
|
Solution For Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
Initial
|
12 May 2021
|
16 December 2024
|
| 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-008
|
Bemiparin sodium
|
Hibor
|
2,500IU anti-Factor Xa/0.2ml
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Renewal
|
10 July 2024
|
08 October 2029
|
| View |
|
BRP-009
|
Bemiparin sodium
|
Hibor
|
3,500IU anti-Factor Xa/0.2mL
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Renewal
|
14 June 2024
|
08 October 2029
|
| View |
|
BRP-010
|
Bemiparin sodium
|
Hibor
|
5,000IU anti-Factor Xa/0.2ml
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Rovi Contract Manufacturing, S.L.
|
Spain
|
Renewal
|
14 June 2024
|
08 October 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
|
| View |
|
BRP-013
|
Insulin Glargine
|
Lantus
|
100 I.U./mL (3.64 mg Insulin glargine equivalent to 100 units Human insulin)
|
Solution For Injection (Sc)
|
-
|
|
|
-
|
05 November 2021
|
17 February 2026
|
| View |
|
BRP-013-01
|
Insulin Glargine
|
Podevta
|
100 I.U./mL (3.64 mg Insulin glargine equivalent to 100 units Human insulin)
|
Solution For Injection (Sc)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
-
|
12 May 2021
|
17 February 2026
|
| View |
|
BRP-014
|
Lantus Solostar
|
Insulin Glargine
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution for Injection (SC)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
Renewal
|
17 February 2023
|
26 February 2028
|
| View |
|
BRP-014-01
|
Insulin Glargine
|
Podevta
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution For Injection (SC)
|
-
|
Sanofi-Aventis Deutschland GmbH
|
|
Renewal
|
22 March 2023
|
26 February 2028
|
| View |
|
BRP-014-02
|
Insulin Glargine
|
None
|
100 Units (equivalent to 3.64 mg)/mL
|
Solution for Injection (SC)
|
Antidiabetics
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
CLIDP Conversion
|
09 January 2024
|
26 February 2028
|