RAPAMUNE

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII W36ZG6FT64 - SIROLIMUS
 

Sirolimus inhibits T-cell activation induced by most stimuli, by blocking calcium-dependent and calcium-independent intracellular signal transduction. Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.

 
Read more about Sirolimus

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RAPAMUNE Coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
L04AH01 Sirolimus L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AH Mammalian target of rapamycin (mTOR) kinase inhibitors
Discover more medicines within L04AH01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 6436R, 6437T, 6457W, 8724E, 8725F, 8833X, 8984W, 9548M, 9549N, 9550P, 9747B, 9748C
BR Câmara de Regulação do Mercado de Medicamentos 522720020083817, 522720020083917
CA Health Products and Food Branch 02243237, 02247111
EE Ravimiamet 1012857, 1107739, 1107740, 1132490, 1132502, 1484647, 1484658, 1849787
ES Centro de información online de medicamentos de la AEMPS 01171001, 01171008, 01171009, 01171013
FI Lääkealan turvallisuus- ja kehittämiskeskus 003353, 011548, 467514
FR Base de données publique des médicaments 61752409, 64597615, 65164182, 69171174
GB Medicines & Healthcare Products Regulatory Agency 184017, 40911, 40916, 45648
HK Department of Health Drug Office 50220, 61049
IE Health Products Regulatory Authority 88340, 88343, 88415
IL מִשְׂרַד הַבְּרִיאוּת 4405, 4804
IT Agenzia del Farmaco 035120017, 035120068, 035120070, 035120094, 035120106, 035120118, 035120120
LT Valstybinė vaistų kontrolės tarnyba 1004272, 1007508, 1010323, 1014606, 1014607, 1056075, 1056076
MX Comisión Federal para la Protección contra Riesgos Sanitarios 099M2000, 125M2001
NL Z-Index G-Standaard, PRK 57908, 63746, 68802
NZ Medicines and Medical Devices Safety Authority 10241, 11283, 14308, 9407
PL Rejestru Produktów Leczniczych 100103636, 100112747, 100127690, 100235970
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65025001
SG Health Sciences Authority 11964P, 12034P, 12647P
TN Direction de la Pharmacie et du Médicament 8013131H, 8063111H
TR İlaç ve Tıbbi Cihaz Kurumu 8681308015099, 8681308015167, 8681308127457, 8681308127464, 8681308597472
US FDA, National Drug Code 0008-1030, 0008-1040, 0008-1041, 0008-1042
ZA Health Products Regulatory Authority 35/34/0009, A38/34/0440

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