Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
ASPAVELI 1,080 mg solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear, colourless to slightly yellowish aqueous solution with pH 5.0. |
Each 20 mL vial contains 1 080 mg of pegcetacoplan.
Each mL contains 54 mg of pegcetacoplan.
Excipients with known effect:
Each mL contains 41 mg of sorbitol.
Each vial contains 820 mg of sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegcetacoplan |
Pegcetacoplan is a symmetrical molecule comprised of two identical pentadecapeptides covalently bound to the ends of a linear 40-kDa PEG molecule. The peptide moieties bind to complement C3 and exert a broad inhibition of the complement cascade. Pegcetacoplan binds to complement protein C3 and its activation fragment C3b with high affinity, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In PNH, extravascular haemolysis (EVH) is facilitated by C3b opsonisation while intravascular haemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). |
| List of Excipients |
|---|
|
Sorbitol (E420) |
A Type I glass vial with a stopper (chlorobutyl), and a seal (aluminium) with a flip-off cap (polypropylene) containing 54 mg/mL of sterile solution.
Each single pack contains 1 vial.
Multipack containing 8 (8 packs of 1) vials.
Not all pack sizes may be marketed.
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
EU/1/21/1595/001
EU/1/21/1595/002
Date of first authorisation: 13 December 2021
| Drug | Countries | |
|---|---|---|
| ASPAVELI | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania |
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