Nityr (nitisinone)
Generic
- Region
- 🇪🇺 EU
- Active substance
- nitisinone
- Company
- Cycle Pharmaceuticals (Europe) Ltd
- Status
- Authorised
- Therapeutic area
- Tyrosinemias
- CHMP opinion
- Thu 31 May 2018
- EU approval
- Thu 26 Jul 2018
- Designations
- Generic
- Application
- EMEA/H/C/004582
- ATC
- A16AX04
- Official record
- www.ema.europa.eu
Indication
Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Orfadin Authorised · Swedish Orphan Biovitrum International AB
- 🇪🇺 Nitisinone MDK (previously Nitisinone MendeliKABS) Withdrawn · MendeliKABS Europe Ltd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.