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Nitisinone Dipharma 2 mg hard capsules



Dipharma Arzneimittel GmbHPA23449/001/003

Main Information

Trade NameNitisinone Dipharma 2 mg hard capsules
Active SubstancesNitisinone
Dosage FormCapsule, hard
Licence HolderDipharma Arzneimittel GmbH
Licence NumberPA23449/001/003

Group Information

ATC CodeA16AX04 nitisinone

Status

License statusAuthorised
Licence Issued01/05/2020
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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