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
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. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
RAPAMUNE Coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
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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