Pelmeg (pegfilgrastim)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- pegfilgrastim
- Company
- Mundipharma Corporation (Ireland) Limited
- Status
- Authorised
- CHMP opinion
- Wed 19 Sep 2018
- EU approval
- Tue 20 Nov 2018
- Designations
- Biosimilar
- Application
- EMEA/H/C/004700
- ATC
- L03AA13
- Official record
- www.ema.europa.eu
Indication
To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
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.
- 🇪🇺 Cegfila (previously Pegfilgrastim Mundipharma) Authorised · Mundipharma Corporation (Ireland) Limited
- 🇪🇺 Vivlipeg Authorised · Biosimilar Collaborations Ireland Limited
- 🇺🇸 Ennumo Approved · Accord Biopharma Inc.
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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.