Alkindi (hydrocortisone)
- Region
- 🇪🇺 EU
- Active substance
- hydrocortisone
- Company
- Immedica Pharma AB
- Status
- Authorised
- Therapeutic area
- Adrenal Insufficiency
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Fri 09 Feb 2018
- Application
- EMEA/H/C/004416
- ATC
- H02AB09
- Official record
- www.ema.europa.eu
Indication
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Efmody Authorised · Immedica Pharma AB
- 🇪🇺 Hydrocortisone Aguettant Application withdrawn · Laboratoire Aguettant
- 🇪🇺 Plenadren Authorised · Takeda Pharmaceuticals International AG Ireland Branch
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.