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PRODUCT DETAIL

FABHALTA 200 mg tvrdé kapsuly

Code 6449E
MA number EU/1/24/1802/002
Product Form: cps dur 56x200 mg (blis.PVC/PE/PVDC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AJ Complement inhibitors
L04AJ08 Iptacopan
Shelf life: 24
Container: blister PVC/PE/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 17.05.2024
Validity: 17.05.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 30.05.2024
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