Susvimo (ranibizumab)
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Roche Registration GmbH
- Status
- Application withdrawn
- Therapeutic area
- Wet Macular Degeneration
- Application
- EMEA/H/C/005610
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Treatment of neovascular age-related macular degeneration in adults.
Regulatory milestones
Fri 18 Sep 2026🇪🇺 EU approval (EC decision)
Susvimo (ranibizumab) approved in the EU
Marketing authorisation to Roche Registration GmbH; Additional monitoring · source
Thu 23 Jul 2026🇪🇺 CHMP positive opinion
Susvimo (ranibizumab): CHMP positive opinion
Roche Registration GmbH; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Fovlussea Opinion · Accord Healthcare S.L.U.
- 🇪🇺 Lucentis Authorised · Novartis Europharm Limited
- 🇪🇺 Byooviz Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Epruvy (previously Ranibizumab Midas) Authorised · Midas Pharma GmbH
- 🇪🇺 Ximluci Authorised · STADA Arzneimittel AG
- 🇪🇺 Susvimo Authorised · Roche Registration GmbH
- 🇪🇺 Vislyfa Authorised · Lupin Europe GmbH
- 🇪🇺 Ranivisio Authorised · Midas Pharma GmbH
- 🇪🇺 Rimmyrah Authorised · Qilu Pharma Spain S.L.
- 🇺🇸 Nufymco Approved · Formycon Ag
- 🇺🇸 Ranluspec Approved · Lupin Limited
- 🇪🇺 Rexatilux Authorised · Intas Third Party Sales 2005 S.L.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.