Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Cycle Pharmaceuticals (Europe) Limited, 70 Sir John Rogersons Quay, Dublin 2, D02 R296, Ireland
Nityr 10 mg tablets.
| Pharmaceutical Form |
|---|
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Tablet. White to beige, round (7 mm), flat tablet, which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side. |
Each tablet contains 10 mg nitisinone.
Excipient with known effect: Each tablet contains 102.99 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, the second step in the tyrosine metabolism. By inhibiting the normal catabolism of tyrosine in patients with hereditary tyrosinemia type 1 (HT-1) and alkaptonuria (AKU), nitisinone prevents the accumulation of harmful metabolites downstream of 4-hydroxyphenylpyruvate dioxygenase. |
| List of Excipients |
|---|
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Glycerol dibehenate |
HDPE 75 mL square bottle with a tamper-evident child-resistant closure of polypropylene (PP). Each bottle contains 60 tablets. Each carton contains 1 bottle.
Cycle Pharmaceuticals (Europe) Limited, 70 Sir John Rogerson’s Quay, Dublin 2, D02 R296, Ireland
EU/1/18/1290/001
Date of first authorisation: 26 July 2018
Date of latest renewal: 04 May 2023
| Drug | Countries | |
|---|---|---|
| NITYR | Austria, Estonia, Croatia, Ireland, Israel, Italy, Lithuania, New Zealand, Poland, United States |
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