AGAMREE

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, France, Ireland, Italy, Lithuania, Romania.

Active ingredients

The drug AGAMREE contains one active pharmaceutical ingredient (API):

1	Vamorolone UNII 8XP29XMB43 - VAMOROLONE
	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.
	Read more about Vamorolone

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
AGAMREE Oral suspension	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
H02AB18		H Systemic hormonal preparations, excl. Sex hormones and insulins → H02 Corticosteroids for systemic use → H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN → H02AB Glucocorticoids
Discover more medicines within H02AB18

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	3063035
FR	Base de données publique des médicaments	61173636
IT	Agenzia del Farmaco	050998018
LT	Valstybinė vaistų kontrolės tarnyba	1098464
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W70659001
US	FDA, National Drug Code	62450-003, 69616-264, 69616-265