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RASILEZ Film-coated tablet (2017)

Active ingredients: Aliskiren

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
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
Magnesium stearate
Microcrystalline cellulose
Povidone
Colloidal anhydrous silica
Hypromellose
Macrogol
Talc
Black iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)

Pack sizes and Marketing

Rasilez 150 mg film-coated tablets

PA/Alu/PVC – Alu blisters:

Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets.
Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) 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

PA/Alu/PVC – Alu blisters:

Unit packs containing 7, 14, 28, 30, 50 or 56 tablets.
Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) 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.

Marketing authorization holder
Authorization dates

Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom

Date of first authorisation: 22 August 2007

Date of latest renewal: 24 August 2012

Marketing authorization number:

Rasilez 150 mg film-coated tablets:

EU/1/07/405/001-010

EU/1/07/405/021-030

Rasilez 300 mg film-coated tablets:

EU/1/07/405/011-020

EU/1/07/405/031-040