|
Code
|
5214E
|
|
MA number
|
EU/1/23/1776/001
|
|
Product Form:
|
sus por 1x100 ml/4 000 mg (fľ.skl.jantár.+adaptér+2 per.striek.)
|
|
MA Status:
|
E - Valid centralised marketing authorisation
|
|
Type of procedure:
|
EU Orphan
|
|
MAH, country:
|
Santhera Pharmaceuticals (Deutschland) GmbH , Germany
|
|
Therapeutic Class:
|
56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
|
|
ATC:
|
| H |
SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS |
| H02 |
CORTICOSTEROIDS FOR SYSTEMIC USE |
| H02A |
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN |
| H02AB |
Glucocorticoids |
| H02AB18 |
Vamorolone |
|
|
Shelf life:
|
36 |
|
Container:
|
amber glass bottle
|
|
Route of admin.:
|
Oral use
|
European Medicines Agency's database
