This medicine is authorised for use in the European Union.


Ximluci 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. Ximluci 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 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.

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

Ximluci contains the active substance ranibizumab.

This EPAR was last updated on 20/06/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetic Retinopathy
  • Diabetes Complications
Anatomical therapeutic chemical (ATC) code
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.


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
STADA Arzneimittel AG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Stadastrasse 2-18
Bad Vilbel

Product information

26/05/2023 Ximluci - EMEA/H/C/005617 - N/0001

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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


Therapeutic indication

Ximluci 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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