Sapropterin Dipharma 500 mg Powder for oral solution

Licence status
Authorised: 16/02/2022
Active substances
Sapropterin hydrochloride
Dosage Form
Powder for oral solution
Licence number
EU/1/21/1620/004
Licence holder
Dipharma Arzneimittel GmbH

Product documents

Licence information

ATC code
A16AX07 sapropterin
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
16/02/2022