Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Rapamune 0.5 mg coated tablets.
Rapamune 1 mg coated tablets.
Rapamune 2 mg coated tablets.
| Pharmaceutical Form |
|---|
|
Coated tablet (tablet). Rapamune 0.5 mg coated tablets: Tan-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 0.5 mg” on one side. Rapamune 1 mg coated tablets: White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1 mg” on one side. Rapamune 2 mg coated tablets: Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side. |
Rapamune 0.5 mg coated tablets: Each coated tablet contains 0.5 mg sirolimus.
Rapamune 1 mg coated tablets: Each coated tablet contains 1 mg sirolimus.
Rapamune 2 mg coated tablets: Each coated tablet contains 2 mg sirolimus.
Excipients with known effect:
Rapamune 0.5 mg coated tablets: Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose.
Rapamune 1 mg coated tablets: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose.
Rapamune 2 mg coated tablets: Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Rapamune 0.5 mg coated tablets: Macrogol Rapamune 1 mg coated tablets: Macrogol Rapamune 2 mg coated tablets: Macrogol |
Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Rapamune 0.5 mg coated tablets: EU/1/01/171/013-14
Rapamune 1 mg coated tablets: EU/1/01/171/007-8
Rapamune 2 mg coated tablets: EU/1/01/171/009-010
Date of first authorisation: 13 March 2001
Date of latest renewal: 13 March 2011
| Drug | Countries | |
|---|---|---|
| RAPAMUNE | 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
