Fabrizyme-β (Fabricor)
Product detail for Fabrizyme-β, INN: fabrizyme beta. Therapeutic area: Rare Disease. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.
Product ID
PROD-010
INN
fabrizyme beta
Therapeutic Area
Rare Disease
Status
Active
Owner
Nadia Petrova
Created
2022-01-28
Last Updated
2024-04-16
Markets
5
Presentations
| Form | Strength | Route |
|---|---|---|
| Soft capsule | 1 mg/mL | Oral |
| Inhalation powder | 5 mg | Subcutaneous |
Active Substances
| ID | Name | INN | CAS | Type | Status |
|---|---|---|---|---|---|
| SUB-008 | Alzabistat | alzabistat | 55813-84-2 | biologic | Active |
| SUB-026 | Ozanemolistat | ozanemolistat | 18057-76-5 | small-molecule | Active |
Applications (4)
| Application # | Market | Procedure Type | Status | Owner | Submitted |
|---|---|---|---|---|---|
| MFDS-2020-0010 | Germany | NDS | Approved | Nadia Petrova | 2023-03-10 |
| MOH-IL-2020-0040 | Germany | BLA | Failed | Sarah Chen | 2024-02-26 |
| MFDS-2020-0070 | Germany | Label Update | Submitted | Lieselotte van der Berg | 2022-12-08 |
| MOH-IL-2020-0100 | Germany | Label Update | Completed | James O'Brien | 2023-10-12 |