Udenyca (pegfilgrastim)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- ERA Consulting GmbH
- Status
- Withdrawn
- CHMP opinion
- Wed 25 Jul 2018
- EU approval
- Fri 21 Sep 2018
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004413
- 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
- 🇪🇺 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.