Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: MendeliKABS Europe Limited, The Light Box, 111 Power Rd, Unit G.07, Chiswick, London, W4 5PY, United Kingdom
Nitisinone MDK 2 mg hard capsules.
Nitisinone MDK 5 mg hard capsules.
Nitisinone MDK 10 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body. White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body. White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body. The capsules contain a white to off white powder. |
Each capsule contains 2 mg nitisinone.
Each capsule contains 5 mg nitisinone.
Each capsule contains 10 mg nitisinone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nitisinone |
Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with hereditary tyrosinemia type 1 (HT-1), nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate. |
| List of Excipients |
|---|
|
Capsule content: Pregelatinised starch (maize) Capsule shell: Gelatin Imprint: Black iron oxide (E172) |
HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Each carton pack contains one bottle.
MendeliKABS Europe Limited, The Light Box, 111 Power Rd, Unit G.07, Chiswick, London, W4 5PY, United Kingdom
EU/1/17/1217/001
EU/1/17/1217/002
EU/1/17/1217/003
Date of first authorisation: 24 August 2017
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