OCTAGAM

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

Active ingredients

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

1	Immunoglobulins, normal human, IV
	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

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	535300203157311, 535300204153415, 535300205151416, 535300206156411, 535300207152411, 535300208159418
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	30307-10-12
EE	Ravimiamet	1013881, 1082584, 1082595, 1315662, 1315673, 1315684, 1315695, 1638660, 1638671, 1638682, 1771714, 1771758, 1771769, 1771770, 1814284
FI	Lääkealan turvallisuus- ja kehittämiskeskus	037992, 157995, 158007, 158018, 158040
FR	Base de données publique des médicaments	65492097, 67255976
GB	Medicines & Healthcare Products Regulatory Agency	150729, 150738, 194704, 194707, 194710, 194716
HR	Agencija za lijekove i medicinske proizvode	HR-H-315670569
IL	מִשְׂרַד הַבְּרִיאוּת	7143, 7144, 7145
LT	Valstybinė vaistų kontrolės tarnyba	1035690, 1035691, 1035692, 1035693, 1073401, 1073402, 1073403, 1082911, 1086501, 1086502, 1086503, 1086504, 1086505, 1086506, 1086507, 1088909
MT	Medicines Authority	MA1219/00201, MA1219/00202, MA1219/00203, MA1219/00204, MA1219/00205, MA1219/00601, MA1219/00602, MA1219/00603, MA1219/00604, MA1219/00605, MA1219/00606
NL	Z-Index G-Standaard, PRK	48062, 48070, 48089, 80055, 80063, 80071, 91308
NZ	Medicines and Medical Devices Safety Authority	12027
PL	Rejestru Produktów Leczniczych	100080622, 100080639, 100193912, 100222619, 100406160
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65624001, W65624002, W65624003, W65624004, W65624005, W65624006, W65624007, W65903001, W65903002, W65903003, W65903004, W65903005, W65903006, W65903007
SG	Health Sciences Authority	10859P
TN	Direction de la Pharmacie et du Médicament	10043021H, 10043022H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699686000002, 8699686000026, 8699686980052, 8699686980090
US	FDA, National Drug Code	68982-840, 68982-850
ZA	Health Products Regulatory Authority	34/30.2/0501