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Human medicines European public assessment report (EPAR): Ximluci, ranibizumab, Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complications, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised

The safety of Ximluci has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis.

The most common side effects affecting the eyes with ranibizumab (which may affect more than 1 in 10 people) are eye pain, ocular hyperaemia (increased blood supply to the eye, leading to redness of the eye), increased intraocular pressure (pressure within the eye), vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (watery eyes), blepharitis (inflammation of the eyelids), dry eye and eye pruritis (itching). Less frequent but more serious side effects include endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and iatrogenic traumatic cataract (clouding of the lens caused by medication). The most common side effects not affecting the eyes are headache, nasopharyngitis (inflammation of the nose and throat) and arthralgia (joint pain).

Ximluci must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of side effects and restrictions of Ximluci, see the package leaflet.

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