OCTAGAM

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

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 about Immunoglobulins, normal human, IV

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

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