NutropinAq (somatropin)
- Region
- 🇪🇺 EU
- Active substance
- somatropin
- Company
- Ipsen Pharma
- Status
- Authorised
- Therapeutic area
- Turner Syndrome; Dwarfism, Pituitary
- EU approval
- Thu 15 Feb 2001
- Application
- EMEA/H/C/000315
- ATC
- H01AC01
- Official record
- www.ema.europa.eu
Indication
Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Skytrofa (previously Lonapegsomatropin Ascendis Pharma) Authorised · Ascendis Pharma Endocrinology Division A/S
- 🇪🇺 Omnitrope Authorised · Sandoz GmbH
- 🇪🇺 Somatropin Biopartners Lapsed · BioPartners GmbH
- 🇪🇺 Valtropin Withdrawn · BioPartners GmbH
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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.