Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
Byooviz 10 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to pale yellow aqueous solution. |
One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult patients.
* Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ranibizumab |
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It binds with high affinity to the VEGF-A isoforms, thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, all of which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, pathologic myopia and CNV or to visual impairment caused by either diabetic macular oedema or macular oedema secondary to RVO in adults and retinopathy of prematurity in preterm infants. |
| List of Excipients |
|---|
|
α,α-trehalose dihydrate |
Vial-only pack:
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Vial + filter needle + injection needle pack:
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution, 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm), and 1 injection needle (30G x ½″, 0.3 mm x 13 mm).
Not all pack types may be marketed.
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
EU/1/21/1572/001
EU/1/21/1572/002
Date of first authorisation: 18 August 2021
| Drug | Countries | |
|---|---|---|
| BYOOVIZ | Estonia, Croatia, Ireland, Lithuania, Poland |
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