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PRODUCT DETAIL

Sapropterin Dipharma 100 mg rozpustné tablety

Code 9849D
MA number EU/1/21/1620/001
Product Form: tbl sol 30x100 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 87 - VARIA I
ATC:
A ALIMENTARY TRACT AND METABOLISM
A16 OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16A OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AX Various alimentary tract and metabolism products
A16AX07 Sapropterin
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 16.02.2022
Validity: 16.02.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.03.2022
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