Is Palifermin approved by the US FDA?

Drugs@FDA lists 1 application product line for Palifermin, including KEPIVANCE (Prescription).

Is Palifermin authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Palifermin.

Are there safety signals or safety updates for Palifermin?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2019-12-18).

Active substance

Palifermin

US FDA 1
EMA 1
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KEPIVANCE	60MCG/KG/DAY	injectable · injection	BIOVITRUM AB	Prescription	15 Dec 2004

EMA European Union — centrally authorised medicines

Kepivance Swedish Orphan Biovitrum AB (publ) · Withdrawn · authorised 25 Oct 2005 · ATC V03AF08

Therapeutic indication (EMA)

Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.

Safety signals and safety-related labeling changes

US FDA 18 Dec 2019 KEPIVANCE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
EMA PRAC 6 Nov 2015 PRAC signal: Infection
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jul 2015 PRAC signal: Infection
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2015 PRAC signal: Increased mortality for unlicensed use in acute lung injury
Action for MAH: update of the product information: No

All safety entries for palifermin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.