CABLIVI Powder and solvent for solution for injection Ref.[7585] Active ingredients: Caplacizumab

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Ablynx NV, Technologiepark 21, 9052, Zwijnaarde, Belgium

Product name and form

Cablivi 10 mg powder and solvent for solution for injection.

Pharmaceutical Form
Powder and solvent for solution for injection. White lyophilised powder. The solvent is a clear, colourless liquid.

Qualitative and quantitative composition

Each vial of powder contains 10 mg of caplacizumab*.

Each pre-filled syringe of solvent contains 1 mL of water for injections.

* Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Caplacizumab	Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets. As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP. It also affects the disposition of von Willebrand factor, leading to transient reductions of total von Willebrand factor antigen levels and to concomitant reduction of factor VIII:C levels during treatment.

List of Excipients
Powder: Sucrose Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80 Solvent: Water for injections

Pack sizes and marketing

Powder: Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), containing 10 mg of caplacizumab.

Solvent: Pre-filled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of water for injections.

Pack size:

Single pack containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 hypodermic needle (30 gauge) and 2 alcohol swabs.
Multipack containing 7 single packs.
Multidose pack containing 7 vials with powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 hypodermic needles (30 gauge) and 14 alcohol swabs.

Not all pack sizes may be marketed.

Marketing authorization holder

Ablynx NV, Technologiepark 21, 9052, Zwijnaarde, Belgium

Marketing authorization dates and numbers

EU/1/18/1305/001

EU/1/18/1305/002

EU/1/18/1305/003

Date of first authorisation: 31 August 2018

Drugs

Drug	Countries
CABLIVI	Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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