GAMMANORM

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

Active ingredients

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

1
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 more about Human normal immunoglobulin G

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 GAMMANORM Solution for injection 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
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)
BR Câmara de Regulação do Mercado de Medicamentos 535318070002907, 535318070003007, 535318070003107, 535318070003207, 535318070003307, 535318070003407
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 92-MBE-0317
EE Ravimiamet 1192317, 1192328, 1192339, 1283857, 1283868, 1283879, 1638334, 1638345, 1638356, 1638367, 1638378, 1638389, 1638390, 1638402, 1638413, 1638424, 1638435, 1638446
FI Lääkealan turvallisuus- ja kehittämiskeskus 096169, 096178, 096205, 096215, 478393, 495245
FR Base de données publique des médicaments 64138003
GB Medicines & Healthcare Products Regulatory Agency 179766, 179769, 324672, 324676, 324680, 325031
HR Agencija za lijekove i medicinske proizvode HR-H-251167379
LT Valstybinė vaistų kontrolės tarnyba 1055298, 1055299, 1058350, 1058351, 1058352, 1058353, 1073116, 1073117, 1073118, 1073119, 1073120, 1073121, 1073122, 1073123, 1073124, 1073125, 1073126, 1073127
MT Medicines Authority MA1219/00401, MA1219/00402, MA1219/00403, MA1219/00404, MA1219/00405, MA1219/00406
NL Z-Index G-Standaard, PRK 199001, 199028, 199036, 199044, 79502, 87084
NZ Medicines and Medical Devices Safety Authority 12555
PL Rejestru Produktów Leczniczych 100162165
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65348001, W65348002, W65348003, W65348004, W65348005, W65348006, W65348007, W65348008, W65348009, W65348010, W65348011, W65348012, W65348013, W65348014, W65348015, W65348016, W65348017, W65348018

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