Vivlipeg (pegfilgrastim)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- Biosimilar Collaborations Ireland Limited
- Status
- Authorised
- Therapeutic area
- Neutropenia; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia; Cancer
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Mon 18 Aug 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006739
- ATC
- L03AA13
- Official record
- www.ema.europa.eu
Indication
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Regulatory milestones
No milestones recorded in the last year.
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
- 🇺🇸 Ennumo Approved · Accord Biopharma Inc.
Follow Vivlipeg
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.