Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Ronapreve 300 mg + 300 mg solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear to slightly opalescent and colourless to pale yellow solution with a pH of 6.0. |
Each casirivimab vial contains 300 mg of casirivimab per 2.5 mL (120 mg/mL).
Each imdevimab vial contains 300 mg imdevimab per 2.5 mL (120 mg/mL).
Casirivimab and imdevimab are two IgG1 recombinant human monoclonal antibodies produced by recombinant DNA technology in Chinese hamster ovary cells.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Casirivimab and imdevimab |
Casirivimab (IgG1Îș) and imdevimab (IgG1λ) are two recombinant human monoclonal antibodies which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2. This prevents RBD binding to the human ACE2 receptor, so preventing virus entry into cells. |
| List of Excipients |
|---|
|
L-histidine |
Ronapreve is provided in 6 mL clear Type 1 glass vials.
Ronapreve 300 mg + 300 mg solution for injection/infusion, single-use vials:
Each carton contains 1 vial of each antibody:
Pack of two 6 mL clear Type I glass vials with butyl rubber stopper containing one vial of 2.5 mL solution of 300 mg of casirivimab and one vial of 2.5 mL solution of 300 mg of imdevimab.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/21/1601/001
Date of first authorisation: 12 November 2021
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
