Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland
Kuvan 100 mg soluble tablets.
| Pharmaceutical Form |
|---|
|
Soluble tablet. Off-white to light yellow soluble tablet with “177” imprinted on one face. |
Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sapropterin |
Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan. The rationale for administration of sapropterin in patients with BH4-responsive PKU is to enhance the activity of the defective phenylalanine hydroxylase and thereby increase or restore the oxidative metabolism of phenylalanine. The rationale for administration of sapropterin in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase. |
| List of Excipients |
|---|
|
Mannitol (E421) |
High-density polyethylene (HDPE) bottle with child-resistant closure. The bottles are sealed with an aluminium seal. Each bottle contains a small plastic tube of desiccant (silica gel).
Each bottle contains 30, 120 or 240 tablets.
1 bottle per carton.
Not all pack sizes may be marketed.
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland
EU/1/08/481/001
EU/1/08/481/002
EU/1/08/481/003
Date of the first authorisation: 02 December 2008
Date of latest renewal: 02 December 2013
| Drug | Countries | |
|---|---|---|
| KUVAN | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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