Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Beovu 120 mg/ml solution for injection in pre-filled syringe.
Beovu 120 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution. |
One ml solution for injection contains 120 mg of brolucizumab*.
* Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Beovu 120 mg/ml solution for injection in pre-filled syringe:
Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
Beovu 120 mg/ml solution for injection:
Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
Excipient with known effect:
Each pre-filled syringe contains 0.03 mg polysorbate 80 in 0.165 ml solution. This corresponds to 0.01 mg polysorbate 80 per dose (0.05 ml).
Each vial contains 0.05 mg polysorbate 80 in 0.23 ml solution. This corresponds to 0.01 mg polysorbate 80 per dose (0.05 ml).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Brolucizumab |
Brolucizumab is a humanised monoclonal single chain Fv (scFv) antibody fragment with a molecular weight of ~26 kDa. Brolucizumab binds with high affinity to VEGF-A isoforms, thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A binding, brolucizumab suppresses endothelial cell proliferation, thereby reducing pathological neovascularisation and decreasing vascular permeability. |
| List of Excipients |
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Sodium citrate |
Pre-filled syringe:
0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter. The pre-filled syringe has a plunger rod and a purple finger grip, and is packed in a sealed blister.
Pack size of 1 pre-filled syringe.
Vial:
0.23 ml sterile solution in a 2 ml glass vial with a coated rubber stopper sealed with an aluminium cap with a purple plastic flip-off disk.
Pack size of 1 vial and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 μm).
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/19/1417/001-002
Date of first authorisation: 13 February 2020
| Drug | Countries | |
|---|---|---|
| BEOVU | Austria, Canada, Cyprus, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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