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PRODUCT DETAIL

Nitisinone Dipharma 20 mg

Code 6976E
MA number 87/0191/24-S
Product Form: cps dur 1x60x20 mg (fľ.HDPE)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Dipharma Arzneimittel GmbH, Germany
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
A16AX04 Nitisinone
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 15.08.2024
Validity: 15.08.2029
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Nitisinone Dipharma 2 mg a 20 mg_07 2024.pdf  
PIL: PIL_Nitisinone Dipharma 2 mg a 20 mg_07 2024.pdf  
Safety feature Yes
Data update: 03.09.2024
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