Overview
Taliglucerase alfa is the recombinant active form of the human lysosomal enzyme, β-glucocerebrosidase. It was approved in 2012 and is marketed under the name Elelyso for use in patients with type 1 Gaucher's disease.
Indication
For the treatment of adult Type 1 Gaucher disease.
Associated Conditions
- Gaucher Disease, Type 1
- Gaucher Disease, Type III
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/04/20 | Not Applicable | Completed | |||
2019/07/01 | Phase 4 | Completed | Ari Zimran | ||
2017/01/16 | Phase 4 | Withdrawn | |||
2014/04/08 | Phase 2 | Completed | Protalix | ||
2012/12/12 | Phase 1 | Completed | Protalix | ||
2011/08/23 | Phase 3 | Completed | |||
2011/08/08 | Phase 3 | Completed | |||
2010/05/28 | Phase 4 | Completed | |||
2009/08/19 | N/A | NO_LONGER_AVAILABLE | |||
2008/07/10 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 0069-0106 | INTRAVENOUS | 200 U in 5 mL | 5/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ELELYSO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200 UNITS/ VIAL | SIN16770P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200Units/vial | 5/3/2023 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ELELYSO taliglucerase alfa rpc 200 units powder for injection | 207695 | Medicine | A | 5/21/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ELELYSO | 02425637 | Powder For Solution - Intravenous | 200 UNIT / VIAL | 9/8/2014 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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