ASPAVELI Solution for infusion Ref.[49950] Active ingredients: Pegcetacoplan

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Product name and form

ASPAVELI 1,080 mg solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless to slightly yellowish aqueous solution with pH 5.0.

Qualitative and quantitative composition

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. The 40-kDa PEG moiety imparts improved solubility and longer residence time in the body after administration of the medicinal product. It is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor.

List of Excipients

Sorbitol (E420)
Glacial acetic acid
Sodium acetate trihydrate
Sodium hydroxide (for pH adjustment)
Water for injection

Pack sizes and marketing

A Type I glass vial with a stopper (cholorobutyl), 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.

Marketing authorization holder

Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Marketing authorization dates and numbers

EU/1/21/1595/001
EU/1/21/1595/002

Date of first authorisation: 13 December 2021

Drugs

Drug Countries
ASPAVELI Estonia, Ireland, Poland, Romania

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