Preferred Label : nitisinone;

MeSH note : used in treatment of hereditary tyrosinaemia type I;

CISMeF synonym : orfadin; orphan brand of nitisinone;

MeSH synonym : 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione; 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione; NTBC cpd;

MeSH Related Number : 104206-65-7;

Registry Number MeSH : 104206-65-7;

Is substance : O;

UNII : K5BN214699;

Details


Main resources

You can consult :


https://www.has-sante.fr/jcms/p_3282779/fr/orfadin-nitisinone-alcaptonurie
2021
false
false
false
France
treatment outcome
insurance, health, reimbursement
alkaptonuria
administration, oral
nitisinone
evaluation of the transparency committee
nitisinone

---
https://www.has-sante.fr/jcms/p_3197623/fr/nitisinone-dipharma
2020
false
false
false
France
French
drugs, generic
nitisinone
nitisinone
evaluation of the transparency committee
cyclohexanones
nitrobenzoates

---
https://www.has-sante.fr/portail/jcms/c_2908655/fr/nitisinone-dipharma
2019
false
true
false
false
France
nitisinone
nitisinone
drugs, generic
administration, oral
treatment outcome
tyrosinemia, type I
adult
child
diet
evaluation of the transparency committee
cyclohexanones
nitrobenzoates

---
https://www.inesss.qc.ca/index.php?id=72&DemandePluginController%5Buid%5D=4535&DemandePluginController%5Bonglet%5D=2&DemandePluginController%5BbackUrl%5D=%252Findex.php%253Fid%253D72%2526no_cache%253D1%2526DemandePluginController%25255Buid%25255D%253D4526%2526DemandePluginController%25255Bonglet%25255D%253D2%2526DemandePluginController%25255BbackUrl%25255D%253D%2525252Findex.php%2525253Fid%2525253D72%25252526no_cache%2525253D1%25252526DemandePluginController%252525255Buid%252525255D%2525253D4469%25252526DemandePluginController%252525255Bonglet%252525255D%2525253D2%25252526DemandePluginController%252525255BbackUrl%252525255D%2525253D%25252525252Findex.php%25252525253Fid%25252525253D72%252525252526no_cache%25252525253D1%252525252526DemandePluginController%2525252525255Buid%2525252525255D%25252525253D4496%252525252526DemandePluginController%2525252525255Bonglet%2525252525255D%25252525253D2&cHash=ab6b5a506ec3e76d8ca989221ed0b59f
2018
false
false
false
Canada
French
canada
drug evaluation
nitisinone
cyclohexanones
nitrobenzoates

---
https://www.ema.europa.eu/medicines/human/EPAR/Nityr
2018
false
false
false
United Kingdom
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
drugs, generic
drug approval
europe
nitisinone
nitisinone
nitisinone
product surveillance, postmarketing
tyrosinemia, type I
administration, oral
enzyme inhibitors
enzyme inhibitors
4-hydroxyphenylpyruvate dioxygenase
drug interactions
pregnancy
breast feeding
adult
child
continuity of patient care
drug evaluation, preclinical
tyrosinemias
cyclohexanones
nitrobenzoates
cyclohexanones
nitrobenzoates

---
https://www.has-sante.fr/portail/jcms/c_2853369/fr/nitisinone-mdk
2018
false
false
false
false
France
French
evaluation of the transparency committee
nitisinone

---
Nitisinone 2 mg, 5 mg, and 10 mg tablets, oral
https://hpr-rps.hres.ca/reg-content/sommaire-motif-decision-detailTwo.php?lang=fr&linkID=SBD00345
2017
false
false
false
Canada
French
English
summary of product characteristics
administration, oral
nitisinone
nitisinone
tablets
drug approval
canada
enzyme inhibitors
enzyme inhibitors
4-hydroxyphenylpyruvate dioxygenase
tyrosinemia, type I
nitisinone
Product containing nitisinone (medicinal product)
treatment outcome
infant, newborn
infant
child
adolescent
risk management
product surveillance, postmarketing
adult
tyrosinemias
cyclohexanones
nitrobenzoates
cyclohexanones
nitrobenzoates

---
https://www.ema.europa.eu/medicines/human/EPAR/nitisinone-mdk-previously-nitisinone-mendelikabs
2017
false
United Kingdom
French
English
syndication feed
drugs, generic
nitisinone
Product containing precisely nitisinone 2 milligram/1 each conventional release oral capsule (clinical drug)
Product containing precisely nitisinone 5 milligram/1 each conventional release oral capsule (clinical drug)
Product containing precisely nitisinone 10 milligram/1 each conventional release oral capsule (clinical drug)
child
tyrosinemias
cyclohexanones
nitrobenzoates
cyclohexanones
enzyme inhibitors
nitrobenzoates
enzyme inhibitors
treatment outcome
drug evaluation
orphan drug production
infant
4-hydroxyphenylpyruvate dioxygenase
nitisinone
nitisinone
drug evaluation
summary of product characteristics
package leaflet
Tyrosinemia type 1

---
https://hpr-rps.hres.ca/reg-content/sommaire-motif-decision-detailTwo.php?lang=fr&linkID=SBD00336
2016
false
false
false
Canada
French
drug information
Product containing precisely nitisinone 2 milligram/1 each conventional release oral capsule (clinical drug)
Product containing precisely nitisinone 5 milligram/1 each conventional release oral capsule (clinical drug)
Product containing precisely nitisinone 10 milligram/1 each conventional release oral capsule (clinical drug)
nitisinone
cyclohexanones
nitrobenzoates

---
https://www.ema.europa.eu/medicines/human/EPAR/Orfadin
2011
false
United Kingdom
French
English
syndication feed
nitisinone
enzyme inhibitors
child
tyrosinemias
cyclohexanones
nitrobenzoates
enzyme inhibitors
treatment outcome
drug evaluation
orphan drug production
infant
4-hydroxyphenylpyruvate dioxygenase
nitisinone
nitisinone
cyclohexanones
nitrobenzoates
drug evaluation
summary of product characteristics
package leaflet
Tyrosinemia type 1

---
http://www.has-sante.fr/portail/display.jsp?id=c_560675
http://www.has-sante.fr/portail/upload/docs/application/pdf/ct-4515_orfadin_.pdf
http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-11/orfadin_ct_4515.pdf
2007
France
French
English
evaluation of the transparency committee
capsules
treatment outcome
nitisinone
administration, oral
nitrobenzoates
cyclohexanones
4-hydroxyphenylpyruvate dioxygenase
enzyme inhibitors
tyrosinemias
orphan drug production
nitisinone
cyclohexanones
nitrobenzoates

---
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26/04/2025


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