| View |
BR-1221_PI_01.pdf
|
BR-1221
|
Adalimumab
|
Humira
|
40 mg /0.4 mL
|
Solution for Injection (SC)
|
Tumor Necrosis Factor Alpha (TNF-a) Inhibitors
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Initial (from Monitored Release)
|
05 August 2022
|
17 July 2027
|
| View |
|
BR-1222
|
Pegfilgrastim
|
Neulastim
|
6 mg/0.6 mL
|
Solution For Injection (SC)
|
-
|
Amgen Manufacturing Limited
|
U.S.A
|
-
|
18 March 2022
|
14 July 2027
|
| View |
|
BR-1223
|
Filgrastim
|
Neupogen
|
300 mcg/mL
|
Solution For Injection (SC/IV)
|
-
|
Amgen Manufacturing Limited
|
U.S.A
|
-
|
18 March 2022
|
14 July 2027
|
| View |
|
BR-1224
|
Filgrastim
|
Biofil
|
300 mcg/mL
|
Solution For Injection (IV/SC)
|
-
|
Sinergium Biotech S.A.
|
Argentine Republic
|
Renewal
|
26 August 2022
|
08 August 2027
|
| View |
BR-1225_PI_01.pdf
|
BR-1225
|
Insulin Degludec + Liraglutide
|
Xultophy
|
100 U/3.6 mg/mL
|
Solution for Injection (SC)
|
-
|
Novo Nordisk A/S
|
Denmark
|
Initial (from Monitored Release)
|
24 October 2022
|
10 August 2027
|
| View |
|
BR-1226
|
Insulin Detemir
|
Levemir Penfill
|
100 U/ml
|
Solution for injection
|
Insulin and analogue for injection, long-acting
|
Novo Nordisk A/S
|
Denmark
|
Renewal
|
09 June 2022
|
05 September 2027
|
| View |
|
BR-1231
|
Botulinum Toxin Type A (from Clostridium botulinum)
|
Xeomin
|
100 units
|
Powder For Solution For Injection (IM)
|
Muscle Relaxant
|
IDT Biologika GmbH
|
Germany
|
Automatic Renewal
|
30 August 2022
|
19 September 2027
|
| View |
|
BR-1232
|
Botulinum Toxin Type A (from Clostridium botulinum)
|
Xeomin
|
50 Units
|
Powder For Solution For Injection (IM)
|
Muscle Relaxant
|
IDT Biologika GmbH
|
Germany
|
Automatic Renewal
|
30 August 2022
|
19 September 2027
|
| View |
|
BR-1233
|
Botulinum Toxin Type A (from Clostridium botulinum)
|
Xeomin
|
100 units
|
Powder For Solution For Injection (IM)
|
Muscle Relaxant
|
Merz Pharma GmbH & co. KGaA
|
Germany
|
Automatic Renewal
|
30 August 2022
|
19 September 2027
|
| View |
|
BR-1234
|
Botulinum Toxin* Type A (*from Clostridium botulinum)
|
Xeomin
|
50 Units
|
Powder for Solution for Injection (IM)
|
Muscle Relaxant
|
Merz Pharma GmbH & Co. KGaA
|
Germany
|
Renewal
|
25 August 2022
|
19 September 2027
|
| View |
|
BR-1235
|
Isophane Insulin Human, Recombinant DNA
|
Jusline N
|
100 units/mL
|
Sterile Suspension For Injection ( Sc )
|
Intermediate-acting Insulin
|
Gulf Pharmaceutical Industries ( Julphar )
|
UAE
|
Renewal
|
28 March 2023
|
14 March 2028
|
| View |
|
BR-1236
|
Regular Insulin Human, Recombinant DNA
|
Jusline R
|
100 units/mL
|
Sterile Suspension For Injection ( Sc )
|
Short-acting Insulin
|
Gulf Pharmaceutical Industries ( Julphar )
|
UAE
|
Renewal
|
20 March 2023
|
14 March 2028
|
| View |
|
BR-1237
|
Neutral Insulin Human + Isophane Insulin Human, Recombinant DNA
|
Jusline 30/70
|
100 units/mL ( 30% as neutral insulin human/ 70% as isophane insulin human )
|
Sterile Suspension For Injection ( Sc )
|
Intermediate-acting Insulin
|
Gulf Pharmaceutical Industries ( Julphar )
|
UAE
|
Renewal
|
22 March 2023
|
14 March 2028
|
| View |
|
BR-1240
|
Trastuzumab
|
Hertraz
|
150 mg
|
Powder for Concentrate for Solution for Infusion
(IV)
|
Monoclonal Antibodies
|
Biocon Biologics India Limited
|
India
|
Initial (from Monitored Release)
|
29 March 2023
|
05 October 2027
|
| View |
|
BR-1241
|
Trastuzumab
|
Hertraz
|
440 mg
|
Powder For Concentrate For Solution For Infusion (IV)
|
Monoclonal Antibodies
|
Biocon Biologics India Limited
|
India
|
Initial (from Monitored Relase) (Correction)
|
22 April 2024
|
05 October 2027
|
| 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
|