FLEBOGAMMA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

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

1	Immunoglobulins, normal human, IV UNII 66Y330CJHS - HUMAN IMMUNOGLOBULIN G
	Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
	Read more about Immunoglobulins, normal human, IV

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FLEBOGAMMA DIF Solution for infusion	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		Classification
J06BA02	Immunoglobulins, normal human, for intravascular adm.	J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BA Immunoglobulins, normal human
Discover more medicines within J06BA02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	510912120002703, 510912120002903, 510912120003003, 510912120003103, 510912120003203, 510912120003303
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H6890913
EE	Ravimiamet	1327711, 1327722, 1327733, 1327744, 1327755, 1510243, 1510254, 1510265
ES	Centro de información online de medicamentos de la AEMPS	07404001, 07404002, 07404003, 07404004, 07404005, 07404006, 07404007, 07404008
FI	Lääkealan turvallisuus- ja kehittämiskeskus	187859, 189020, 469391
FR	Base de données publique des médicaments	60534795, 64181442
GB	Medicines & Healthcare Products Regulatory Agency	160769, 160771, 160775, 160778
IL	מִשְׂרַד הַבְּרִיאוּת	7146, 7147, 7148, 7149
LT	Valstybinė vaistų kontrolės tarnyba	1028407, 1028408, 1028409, 1028410, 1028411, 1058054, 1058055, 1058056
NL	Z-Index G-Standaard, PRK	48070, 48089, 77976
NZ	Medicines and Medical Devices Safety Authority	14467, 17816
PL	Rejestru Produktów Leczniczych	100231274, 100239258
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W52560002, W52560003, W52560004, W64061001, W69115001
SG	Health Sciences Authority	13960P, 14158P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699769980146, 8699769980153, 8699769980399, 8699769980405, 8699769980412
US	FDA, National Drug Code	61953-0004, 61953-0005