RANIVISIO Solution for injection Ref.[50220] Active ingredients: Ranibizumab

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Midas Pharma GmbH, Rheinstraße 49, D-55218 Ingelheim, Germany

Product name and form

Ranivisio 10 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless to pale yellow aqueous solution.

Qualitative and quantitative composition

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
Histidine hydrochloride, monohydrate
Histidine
Polysorbate 20
Water for injections

Pack sizes and marketing

One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.

Pack size of one vial.

Marketing authorization holder

Midas Pharma GmbH, Rheinstraße 49, D-55218 Ingelheim, Germany

Marketing authorization dates and numbers

Date of first authorisation: 25 August 2022

Drugs

Drug Countries
RANIVISIO Austria, Estonia, Spain, France, Croatia, Italy, Lithuania, Romania

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