Holoclar
·
- Prescription status not stated
- Eyes and ears
- Used in
- Eyes and ears
- Made by
- Holostem s.r.l.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Holostem s.r.l. |
|---|---|
| Active substance | Ex vivo expanded autologous human corneal epithelial cells containing stem cells |
| Used in | Eyes and ears |
| Classification | S01XA19 · Eyes and ears |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2015-02-17 |
| Last updated by the regulator | 2025-07-08 |
| EMA product number | EMEA/H/C/002450 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).