FLEBOGAMMA

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

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 about Immunoglobulins, normal human, IV

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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