FULPHILA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, New Zealand, Poland, Romania.

Active ingredients

The drug FULPHILA contains one active pharmaceutical ingredient (API):

1
UNII 3A58010674 - PEGFILGRASTIM
 

Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.

 
Read more about Pegfilgrastim

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FULPHILA Solution for injection MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L03AA13 Pegfilgrastim L Antineoplastic and immunomodulating agents → L03 Immunostimulants → L03A Immunostimulants → L03AA Colony stimulating factors
Discover more medicines within L03AA13

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 6363X, 9514R
BR Câmara de Regulação do Mercado de Medicamentos 541521010018407
CA Health Products and Food Branch 02484153
EE Ravimiamet 1783076
FI Lääkealan turvallisuus- ja kehittämiskeskus 107460
FR Base de données publique des médicaments 60457929
HK Department of Health Drug Office 66770
IL מִשְׂרַד הַבְּרִיאוּת 8639
LT Valstybinė vaistų kontrolės tarnyba 1086597, 1086599
NZ Medicines and Medical Devices Safety Authority 20523
PL Rejestru Produktów Leczniczych 100416507
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65788001, W65788002
US FDA, National Drug Code 67457-833

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