Nitisinone MDK (previously Nitisinone MendeliKABS) (nitisinone)
Generic
- Region
- 🇪🇺 EU
- Active substance
- nitisinone
- Company
- MendeliKABS Europe Ltd
- Status
- Withdrawn
- Therapeutic area
- Tyrosinemias
- CHMP opinion
- Thu 22 Jun 2017
- EU approval
- Thu 24 Aug 2017
- Designations
- Generic
- Application
- EMEA/H/C/004281
- ATC
- A16AX04
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Orfadin Authorised · Swedish Orphan Biovitrum International AB
- 🇪🇺 Nityr Authorised · Cycle Pharmaceuticals (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.