Overview
Human interferon beta (166 residues), glycosylated, MW=22.5kD. It is produced by mammalian cells (Chinese Hamster Ovary cells) into which the human interferon beta gene has been introduced. The amino acid sequence is identical to that of natural human interferon beta.
Background
Human interferon beta (166 residues), glycosylated, MW=22.5kD. It is produced by mammalian cells (Chinese Hamster Ovary cells) into which the human interferon beta gene has been introduced. The amino acid sequence is identical to that of natural human interferon beta.
Indication
For treatment of relapsing/remitting multiple sclerosis, also for condyloma acuminatum
Associated Conditions
- Relapsing Multiple Sclerosis (RMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/31 | Phase 2 | Not yet recruiting | |||
2024/07/19 | Phase 2 | Recruiting | |||
2023/09/26 | N/A | Active, not recruiting | |||
2023/08/31 | Phase 2 | Recruiting | German Society for Pediatric Oncology and Hematology GPOH gGmbH | ||
2022/12/20 | N/A | Recruiting | |||
2022/03/28 | Phase 2 | Recruiting | |||
2021/08/27 | Not Applicable | Completed | |||
2021/02/01 | Phase 3 | Completed | |||
2020/12/01 | Phase 3 | UNKNOWN | |||
2020/08/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Biogen Inc. | 59627-002 | INTRAMUSCULAR | 30 ug in 0.5 mL | 11/22/2022 | |
| EMD Serono, Inc. | 44087-3344 | SUBCUTANEOUS | 44 ug in 0.5 mL | 7/31/2023 | |
| EMD Serono, Inc. | 44087-0022 | SUBCUTANEOUS | 22 ug in 0.5 mL | 7/31/2023 | |
| EMD Serono, Inc. | 44087-0044 | SUBCUTANEOUS | 44 ug in 0.5 mL | 7/31/2023 | |
| EMD Serono, Inc. | 44087-3322 | SUBCUTANEOUS | 22 ug in 0.5 mL | 7/31/2023 | |
| Biogen Inc. | 59627-003 | INTRAMUSCULAR | 30 ug in 0.5 mL | 11/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/3/1998 | ||
Authorised | 3/13/1997 | ||
Authorised | 3/13/1997 | ||
Authorised | 5/3/1998 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Rebif Solution for Injection in Cartridge 22mcg/0.5ml | SIN13974P | INJECTION, SOLUTION | 22mcg/0.5ml | 6/17/2011 | |
| Rebif Solution for Injection in Cartridge 44mcg/0.5ml | SIN13975P | INJECTION, SOLUTION | 44mcg/0.5ml | 6/17/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AVONEX SOLUTION FOR INJECTION IN PRE-FILLED PEN 30MCG/0.5ML | N/A | N/A | N/A | 10/22/2013 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| REBIF 44 interferon beta-1a (rch) 132 microgram/1.5mL solution for injection multidose cartridge | 165746 | Medicine | A | 1/21/2010 | |
| REBIF 22 interferon beta-1a (rch) 22 microgram/0.5mL injection pre-filled syringe | 133809 | Medicine | A | 12/5/2008 | |
| AVONEX interferon beta-1a (rch) 30microgram/0.5mL injection pre-filled syringe | 95419 | Medicine | A | 5/4/2004 | |
| REBIF 22 interferon beta-1a (rch) 66 microgram/1.5mL solution for injection multidose cartridge | 165745 | Medicine | A | 1/21/2010 | |
| REBIF 44 interferon beta-1a (rch) 44 microgram/0.5mL injection pre-filled syringe autoinjector | 174479 | Medicine | A | 10/21/2010 | |
| REBIF 44 interferon beta-1a (rch) 44 microgram/0.5mL injection pre-filled syringe | 133813 | Medicine | A | 12/5/2008 | |
| AVONEX PEN | 180136 | Medicine | A | 11/22/2011 | |
| REBIF 22 interferon beta-1a (rch) 22 microgram/0.5mL injection pre-filled syringe autoinjector | 174478 | Medicine | A | 10/21/2010 |