Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
FABHALTA 200 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Size 0 pale yellow, opaque hard capsule (21.2 to 22.2 mm) with “LNP200” on the body and “NVR” on the cap, containing white or almost white to pale purplish-pink powder. |
Each capsule contains iptacopan hydrochloride monohydrate equivalent to 200 mg iptacopan.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Iptacopan |
Iptacopan is a proximal complement inhibitor that targets Factor B (FB) to selectively inhibit the alternative pathway. Inhibition of FB in the alternative pathway of the complement cascade prevents the activation of C3 convertase and the subsequent formation of C5 convertase to control both C3-mediated extravascular haemolysis (EVH) and terminal complement-mediated intravascular haemolysis (IVH). |
| List of Excipients |
|---|
|
Capsule shell: Gelatin Printing ink: Black iron oxide (E172) |
FABHALTA is supplied in PVC/PE/PVDC blisters with aluminium foil backing.
Packs containing 28 or 56 hard capsules.
Multipacks containing 168 (3 packs of 56) hard capsules.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/24/1802/001-003
| Drug | Countries | |
|---|---|---|
| FABHALTA | Lithuania, United States |
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