View |
|
BR-1243
|
Human Normal Immunoglobulin
|
Privigen
|
100 mg/mL (10% w/v)
|
Solution for Infusion (IV)
|
-
|
CSL Behring AG
|
Switzerland
|
Renewal
|
28 June 2022
|
05 October 2027
|
View |
|
BR-1244
|
Human Normal Immunoglobulin
|
Privigen
|
100 mg/mL (10% w/v)
|
Solution for Infusion (IV)
|
-
|
CSL Behring AG
|
Switzerland
|
Renewal
|
28 June 2022
|
05 October 2027
|
View |
BR-1247_PI_01.pdf
|
BR-1247
|
Follitropin Alfa
|
Follitrope
|
75 IU / 0.15 mL
|
Solution for Injection (I.M./S.C.)
|
-
|
LG Chem, Ltd.
|
Korea
|
Initial (from Monitored Release)
|
02 October 2023
|
06 October 2027
|
View |
BR-1248_PI_01.pdf
|
BR-1248
|
Follitropin Alfa
|
Follitrope
|
150 IU / 0.3 mL
|
Solution for Injection (SC/IM)
|
-
|
LG Chem, Ltd.
|
Korea
|
Initial (from Monitored Release)
|
15 March 2023
|
06 October 2027
|
View |
BR-1249_PI_01.pdf
|
BR-1249
|
Follitropin Alfa
|
Follitrope
|
225 IU/0.45 mL
|
Solution for Injection (SC/IM)
|
-
|
LG Chem, Ltd.
|
Korea
|
Initial (from Monitored Release)
|
15 March 2023
|
06 October 2027
|
View |
BR-1250_PI_01.pdf
|
BR-1250
|
Follitropin Alfa
|
Follitrope
|
300 IU / 0.6 mL
|
Solution for Injection (SC/IM)
|
-
|
LG Chem, Ltd.
|
Korea
|
Initial (from Monitored Release)
|
15 March 2023
|
06 October 2027
|
View |
|
BR-1251
|
Heparin Sodium
|
None
|
1000 IU/mL
|
Solution For Injection (IV/SC)
|
-
|
AIN Medicare Sdn. Bhd.
|
Malaysia
|
Renewal
|
27 June 2022
|
06 August 2027
|
View |
|
BR-1252
|
Nimotuzumab
|
TheraCIM
|
50 mg/10 mL
|
Solution For IV Infusion
|
-
|
Center of Molecular Immunology (CIM)
|
Cuba
|
Automatic Renewal
|
14 October 2022
|
28 September 2027
|
View |
|
BR-1254
|
Menotrophin
|
Humog 150
|
150 IU
|
Solution for Injection
|
GONADOTROPHIN
|
Bharat Biotech International Ltd.
|
India
|
Automatic Renewal
|
27 December 2022
|
04 January 2028
|
View |
|
BR-1255
|
Menotrophin
|
Humog 75
|
75 IU
|
Solution for Injection
|
GONADOTROPHIN
|
Bharat Biotech International Ltd.
|
India
|
Automatic Renewal
|
16 December 2022
|
04 January 2028
|
View |
|
BR-1259
|
Chorionic Gonadotrophin
|
Hucog-5,000 Hp
|
5,000 IU
|
Solution For Injection/ 5000 I.U.
|
Gonadotropins
|
Bharat Serums and Vaccine Limited
|
India
|
Automatic Renewal
|
13 December 2022
|
26 January 2028
|
View |
|
BR-1261
|
Urofollitropin
|
Foliculin -75 HP
|
75 IU
|
Lyophilized Powder for Solution for Injection (IM/SC)
|
-
|
Bharat Serums and Vaccines Limited
|
India
|
-
|
18 February 2022
|
05 March 2026
|
View |
|
BR-1263
|
Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Haemophilus influenza B Tyoe (Hib) Vaccine
|
Eupenta
|
|
Solution for IM Injection
|
Vaccine
|
LG Chem Limited
|
Korea
|
Renewal
|
03 January 2023
|
13 March 2028
|
View |
|
BR-1264
|
Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Haemophilus influenza B Tyoe (Hib) Vaccine
|
Eupenta
|
|
Solution for IM Injection
|
Vaccine
|
LG Chem Limited
|
Korea
|
Renewal
|
04 January 2023
|
13 March 2028
|
View |
BR-1265_PI_01.pdf
|
BR-1265
|
Adalimumab
|
Humira
|
40mg/ 0.4mL
|
Solution for Injection, Pre-Filled Pen (Mai)
|
Antirheumatic
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
24 September 2019
|
22 March 2025
|
View |
|
BR-1268
|
Insulin aspart
|
Fiasp Flextouch
|
100 Units/mL
|
Solution for Injection (SC/IV)
|
-
|
Novo Nordisk A/S
|
Denmark
|
Renewal
|
19 October 2023
|
09 May 2028
|
View |
BR-1270_PI_01.pdf
|
BR-1270
|
Insulin Glargine/ Lixisenatide
|
Soliqua
|
3.64 mg (equivalent to 100 Units of Insulin glargine) / 50 mcg per mL
|
Solution for Injection (SC)
|
Long-acting Insulin and Analogue.
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
Initial (from Monitored Release)
|
06 March 2024
|
09 May 2028
|
View |
BR-1271_PI_01.pdf
|
BR-1271
|
Insulin Glargine/ Lixisenatide
|
Soliqua
|
3.64 mg (equivalent to 100 Units of Insulin glargine) / 33 mcg per mL
|
Solution for Injection (SC)
|
Long-acting Insulin and Analogue
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
Initial (from Monitored Release)
|
06 March 2024
|
09 May 2028
|
View |
|
BR-1272
|
Der Pte Extract (Dermatophagoides Pteronyssinus + Der Far Extract (Dermatophagoides Farinae)
|
Acarizax
|
6 SQ-HDM per active substance
|
Tablet
|
Immunotherapy
|
Catalent UK Swindon Zydis Limited
|
United Kingdom
|
Monitored Release
|
04 June 2018
|
04 June 2024
|
View |
|
BR-1275
|
Human Albumin
|
Alburx
|
200 g/L (20% w/v)
|
Solution for Intravenous Infusion
|
Plasma fractions for specific uses
|
CSL Behring AG
|
Switzerland
|
BR-1275
|
31 December 2022
|
07 June 2028
|