Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Noden Pharma DAC, DOlier Chambers, 16A DOlier Street, Dublin 2, Ireland
Rasilez 150 mg film-coated tablets.
Rasilez 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Rasilez 150 mg film-coated tablets: Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side. Rasilez 300 mg film-coated tablets: Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side. |
Rasilez 150 mg film-coated tablets: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Rasilez 300 mg film-coated tablets: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Aliskiren |
Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin. By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II. |
| List of Excipients |
|---|
|
Crospovidone, type A |
Rasilez 150 mg film-coated tablets:
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters:
Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Unit packs containing 56x1 tablets in perforated unit dose blisters.
Multipacks containing 280 (20x14) tablets.
Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Rasilez 300 mg film-coated tablets:
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters:
Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Unit packs containing 56x1 tablets in perforated unit dose blisters.
Multipacks containing 280 (20x14) tablets.
Multipacks containing 98 (2x49x1) tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Noden Pharma DAC, D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland
Rasilez 150 mg film-coated tablets: EU/1/07/405/021-030
Rasilez 300 mg film-coated tablets: EU/1/07/405/031-040
Date of first authorisation: 22 August 2007
Date of latest renewal: 22 May 2017
| Drug | Countries | |
|---|---|---|
| RASILEZ | Austria, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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