RAPAMUNE Coated tablet Ref.[8468] Active ingredients: Sirolimus

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

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.

Qualitative and quantitative composition

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
Macrogol
Magnesium stearate
Talc

Tablet coating:

Rapamune 0.5 mg coated tablets:

Macrogol
Glycerol monooleate
Pharmaceutical glaze (shellac)
Calcium sulfate
Microcrystalline cellulose
Sucrose
Titanium dioxide
Yellow iron oxide (E172)
Brown iron oxide (E172)
Poloxamer 188
α-tocopherol
Povidone
Carnauba wax
Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone)

Rapamune 1 mg coated tablets:

Macrogol
Glycerol monooleate
Pharmaceutical glaze (shellac)
Calcium sulfate
Microcrystalline cellulose
Sucrose
Titanium dioxide
Poloxamer 188
α-tocopherol
Povidone
Carnauba wax
Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone)

Rapamune 2 mg coated tablets:

Macrogol
Glycerol monooleate
Pharmaceutical glaze (shellac)
Calcium sulfate
Microcrystalline cellulose
Sucrose
Titanium dioxide
Yellow iron oxide (E172)
Brown iron oxide (E172)
Poloxamer 188
α-tocopherol
Povidone
Carnauba wax
Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone)

Pack sizes and marketing

Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
RAPAMUNE Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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