Fulphila

Application withdrawn

Human

Biosimilar

Details

EMA number	EMEA/H/C/004262
ATC code	L03AA13
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Reducing neutropenia in patients taking cancer treatments

Group: Immunostimulants

Active substances

pegfilgrastim

Marketing Authorisation Holder

MAH

Mylan S.A.S.

MAH

🇺🇸 Also approved in the US (FDA)

NYVEPRIA — HOSPIRA INC, approved 2026-05-21 (BLA761111).

Most reported adverse events (US / FAERS)

79,576 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

device adhesion issue

11,602

wrong technique in product usage process

10,251

unintentional medical device removal

8,985

device malfunction

Timeline

Filter by authority:

Fulphila authorised

20 Nov 2018

authorisedregulatory

Status changed: Authorised → Application withdrawn

29 May 2018

status_changedregulatory

🇺🇸 Also approved in the US (FDA)

NYVEPRIA — HOSPIRA INC, approved 2026-05-21 (BLA761111).

Most reported adverse events (US / FAERS)

79,576 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

device adhesion issue

11,602

wrong technique in product usage process

10,251

unintentional medical device removal

8,985

device malfunction

7,524

device use error

6,052

device issue

5,159

accidental exposure to product

5,033

off label use

3,855

febrile neutropenia

3,803

device occlusion

3,308

death

3,077

bone pain

2,983

neutropenia

2,714

fatigue

2,669

pyrexia

2,561