This brand name is authorized in Austria, Estonia, Croatia, Ireland, Lithuania, United States
The drug AGAMREE contains one active pharmaceutical ingredient (API):
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1
Vamorolone
UNII 8XP29XMB43 - VAMOROLONE
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Vamorolone is a dissociative corticosteroid that selectively binds to the glucocorticoid receptor, which triggers anti-inflammatory effects via inhibition of NF-kB mediated gene transcripts, but leads to less transcriptional activation of other genes. In addition, vamorolone inhibits the activation of the mineralocorticoid receptor by aldosterone. Due to its specific structure, vamorolone is likely not a substrate for 11β-hydroxysteroid dehydrogenases and is therefore not subject to local tissue amplification. The precise mechanism by which vamorolone exerts its therapeutic effects in patients with DMD is unknown. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| AGAMREE Oral suspension | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| H02AB18 | H Systemic hormonal preparations, excl. Sex hormones and insulins → H02 Corticosteroids for systemic use → H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN → H02AB Glucocorticoids | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 3063035 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1098464 |
| Country: US | FDA, National Drug Code | Identifier(s): 62450-003, 69616-264, 69616-265 |
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