Cavoley (pegfilgrastim)
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- STADA Arzneimittel AG
- Status
- Application withdrawn
- Application
- EMEA/H/C/004342
- ATC
- L03AA13
- Official record
- www.ema.europa.eu
Indication
Treatment of neutropenia
Regulatory milestones
Fri 25 Sep 2026🇪🇺 EU approval (EC decision)
Cavoley (pegfilgrastim) approved in the EU
Marketing authorisation to CuraTeQ Biologics s.r.o; Biosimilar, Additional monitoring · source
Thu 23 Jul 2026🇪🇺 CHMP positive opinion
Cavoley (pegfilgrastim): CHMP positive opinion
CuraTeQ Biologics s.r.o; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇺🇸 Armlupeg Approved · Lupin Ltd
- 🇪🇺 Nylaspeg Authorised · Qilu Pharma Spain S.L.
- 🇪🇺 Cavoley Authorised · CuraTeQ Biologics s.r.o
- 🇪🇺 Ziextenzo Authorised · Sandoz GmbH
- 🇪🇺 Grasustek Authorised · Juta Pharma GmbH
- 🇪🇺 Fulphila Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Dyrupeg Authorised · CuraTeQ Biologics (Malta) Limited
- 🇪🇺 Pelgraz Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Lonquex Authorised · Teva B.V.
- 🇪🇺 Pelmeg Authorised · Mundipharma Corporation (Ireland) Limited
- 🇪🇺 Cegfila (previously Pegfilgrastim Mundipharma) Authorised · Mundipharma Corporation (Ireland) Limited
- 🇪🇺 Vivlipeg Authorised · Biosimilar Collaborations Ireland Limited
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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.