PIASKY Solution for injection/infusion Ref.[111488] Active ingredients: Crovalimab

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Product name and form

Piasky 340 mg solution for injection/infusion.

Pharmaceutical Form
Solution for injection/infusion. Clear to strongly opalescent and almost colourless to brownish-yellow solution. The solution has a pH of approximately 5.8 and an osmolality of approximately 297 mOsm/kg.

Qualitative and quantitative composition

Each 2 mL vial contains 340 mg of crovalimab.

Each mL of solution for injection/infusion contains 170 mg crovalimab.

Crovalimab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Crovalimab	Crovalimab is a recombinant humanised immunoglobulin G1 (IgG1)-based monoclonal antibody that specifically binds with high affinity to component 5 (C5) of the complement system, inhibiting its cleavage into C5a and C5b and thus preventing the formation of the membrane attack complex (MAC). Crovalimab causes terminal complement activity inhibition. In patients with PNH, crovalimab inhibits terminal complement-mediated intravascular haemolysis.

List of Excipients
Histidine Aspartic acid Arginine hydrochloride Poloxamer 188 Water for injections

Pack sizes and marketing

Solution for injection/infusion in a 2 mL single-use vial (Type I glass) with a stopper (rubber) and a seal (aluminium).

Each carton contains one vial.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/24/1848/001

Drugs

Drug	Countries
PIASKY	Lithuania, United States

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