RAPAMUNE

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

Active ingredients

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

1 Sirolimus
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 about Sirolimus

Medication package inserts

Below package inserts are available for further reading:

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

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