Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Ronapreve 120 mg/mL solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion (sterile concentrate). Clear to slightly opalescent and colourless to pale yellow solution with a pH of 6.0. |
Each casirivimab 6 mL vial contains 300 mg of casirivimab per 2.5 mL (120 mg/mL).
Each imdevimab 6 mL vial contains 300 mg imdevimab per 2.5 mL (120 mg/mL).
Each casirivimab 20 mL multidose vial contains 1 332 mg of casirivimab per 11.1 mL (120 mg/mL).
Each imdevimab 20 mL multidose vial contains 1 332 mg imdevimab per 11.1 mL (120 mg/mL).
Casirivimab and imdevimab are two neutralising 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 clear Type 1 glass vials in 20 mL or 6 mL vials.
Each carton contains 2 vials per package:
Ronapreve 120 mg/mL solution for infusion or injection, multidose vials:
Pack of two 20 mL clear Type I glass vials with butyl rubber stopper containing one vial of 11.1 mL solution of 1 332 mg of casirivimab and one vial of 11.1 mL solution of 1 332 mg of imdevimab.
Ronapreve 120 mg/ml solution for infusion or injection, single-use vial:
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 Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
PLGB 00031/0925
Date of first authorisation: 19 August 2021
| Drug | Countries | |
|---|---|---|
| RONAPREVE | Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom |
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