Source: European Medicines Agency (EU) Revision Year: 2022 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.
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. Increased levels of signalling through the vascular endothelial growth factor A (VEGF-A) pathway are associated with pathological ocular angiogenesis and retinal oedema. Brolucizumab binds with high affinity to VEGF-A isoforms (e.g. VEGF110, VEGF121, and VEGF165), 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 |
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.
0.230 ml sterile solution in a 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).
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/19/1417/001-002
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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