GAMMANORM

This brand name is authorized in Austria, Brazil, Ecuador, Estonia, Finland, France, Croatia, Ireland, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, United Kingdom

Active ingredients

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

1 Human normal immunoglobulin G
UNII 66Y330CJHS - HUMAN IMMUNOGLOBULIN G

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors.

Read about Human normal immunoglobulin G

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
GAMMANORM Solution for injection 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
J06BA01 Immunoglobulins, normal human, for extravascular adm. J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BA Immunoglobulins, normal human
Discover more medicines within J06BA01

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): 535318070002907, 535318070003007, 535318070003107, 535318070003207, 535318070003307, 535318070003407
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 92-MBE-0317
Country: EE Ravimiamet Identifier(s): 1192317, 1192328, 1192339, 1283857, 1283868, 1283879, 1638334, 1638345, 1638356, 1638367, 1638378, 1638389, 1638390, 1638402, 1638413, 1638424, 1638435, 1638446
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 096169, 096178, 096205, 096215, 478393, 495245
Country: FR Base de données publique des médicaments Identifier(s): 64138003
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 179766, 179769, 324672, 324676, 324680, 325031
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1055298, 1055299, 1058350, 1058351, 1058352, 1058353, 1073116, 1073117, 1073118, 1073119, 1073120, 1073121, 1073122, 1073123, 1073124, 1073125, 1073126, 1073127
Country: MT Medicines Authority Identifier(s): MA1219/00401, MA1219/00402, MA1219/00403, MA1219/00404, MA1219/00405, MA1219/00406
Country: NL Z-Index G-Standaard, PRK Identifier(s): 199001, 199028, 199036, 199044, 79502, 87084
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 12555
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100162165
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65348001, W65348002, W65348003, W65348004, W65348005, W65348006, W65348007, W65348008, W65348009, W65348010, W65348011, W65348012, W65348013, W65348014, W65348015, W65348016, W65348017, W65348018

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