Byooviz

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ranibizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Byooviz is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces. Byooviz is used to treat:

  • ‘wet’ form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
  • macular oedema (swelling of the macula) caused by diabetes or by occlusion (blockage) of the veins behind the retina;
  • proliferative diabetic retinopathy (growth of abnormal tiny blood vessels in the eye, associated with diabetes);
  • other sight problems associated with choroidal neovascularisation.

Byooviz is a ‘biosimilar medicine’. This means that Byooviz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Byooviz is Lucentis. For more information on biosimilar medicines, see here.

Byooviz contains the active substance ranibizumab.

This EPAR was last updated on 11/04/2022

Authorisation details

Product details
Name
Byooviz
Agency product number
EMEA/H/C/005545
Active substance
ranibizumab
International non-proprietary name (INN) or common name
ranibizumab
Therapeutic area (MeSH)
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetic Retinopathy
  • Myopia, Degenerative
Anatomical therapeutic chemical (ATC) code
S01LA04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Samsung Bioepis NL B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
18/08/2021
Contact address

Olof Palmestraat 10
2616 LR Delft
The Netherlands

Product information

11/04/2022 Byooviz - EMEA/H/C/005545 - IB/0003

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Byooviz is indicated in adults for:

  • The treatment of neovascular (wet) age-related macular degeneration (AMD)
  • The treatment of visual impairment due to diabetic macular oedema (DME)
  • The treatment of proliferative diabetic retinopathy (PDR)
  • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)

The treatment of visual impairment due to choroidal neovascularisation (CNV)

Assessment history

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