Orfadin (nitisinone)
- Region
- 🇪🇺 EU
- Active substance
- nitisinone
- Company
- Swedish Orphan Biovitrum International AB
- Status
- Authorised
- Therapeutic area
- Tyrosinemias
- CHMP opinion
- Thu 18 Nov 2004
- EU approval
- Mon 21 Feb 2005
- Application
- EMEA/H/C/000555
- ATC
- A16AX04
- Official record
- www.ema.europa.eu
Indication
Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nityr Authorised · Cycle Pharmaceuticals (Europe) Ltd
- 🇪🇺 Nitisinone MDK (previously Nitisinone MendeliKABS) Withdrawn · MendeliKABS Europe Ltd
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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.