Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, D-79539 Lรถrrach, GERMANY, office@santhera.com
AGAMREE 40 mg/ml oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. White to off-white suspension. |
Each ml of suspension contains 40 mg of vamorolone.
Excipient with known effect: The suspension contains 1 mg sodium benzoate (E211) in each ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 11ฮฒ-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. |
| List of Excipients |
|---|
|
Citric acid (monohydrate) (E330) |
Amber coloured glass bottle containing 100 ml oral suspension with a polypropylene tamper evident child resistant closure with low density polyethylene liner.
Each pack contains one bottle, one press-in bottle adapter (low density polyethylene) and two identical oral syringes (low density polyethylene) graduated from 0 to 8 ml by increments of 0.1 ml.
Santhera Pharmaceuticals (Deutschland) GmbH, Marie-Curie Strasse 8, D-79539 Lรถrrach, GERMANY, office@santhera.com
EU/1/23/1776/001
| Drug | Countries | |
|---|---|---|
| AGAMREE | Austria, Estonia, Croatia, Ireland, Lithuania, United States |
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