TASIGNA 50/200mg Hard capsule Ref.[9048] Active ingredients: Nilotinib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Tasigna 50 mg hard capsules.

Tasigna 200 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Tasigna 50 mg hard capsules: White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap.

Tasigna 200 mg hard capsules: White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”.

Qualitative and quantitative composition

Tasigna 50 mg hard capsules: One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).

Excipient with known effect: One hard capsule contains 39.03 mg lactose monohydrate.

Tasigna 200 mg hard capsules: One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).

Excipient with known effect: One hard capsule contains 156.11 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nilotinib

Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein. Nilotinib selectively inhibits the proliferation and induces apoptosis in cell lines and in primary Philadelphia-chromosome positive leukaemia cells from CML patients. In murine models of CML, as a single agent nilotinib reduces tumour burden and prolongs survival following oral administration.
List of Excipients

Tasigna 50 mg hard capsules

Capsule content:

Lactose monohydrate
Crospovidone Type A
Poloxamer 188
Colloidal anhydrous silica
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172

Printing ink:

Shellac
Black iron oxide (E172)
Propylene glycol
Ammonium hydroxide

Tasigna 200 mg hard capsules

Capsule content:

Lactose monohydrate
Crospovidone Type A
Poloxamer 188
Colloidal anhydrous silica
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)

Printing ink:

Shellac (E904)
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Strong ammonia solution
Potassium hydroxide
Red iron oxide (E172)

Pack sizes and marketing

Tasigna is available in the following pack sizes:

Tasigna 50 mg hard capsules:

PVC/PVDC/Alu blisters:

  • Pack containing 120 (3 packs of 40) hard capsules.

Tasigna 200 mg hard capsules

PVC/PVDC/Alu blisters:

  • Unit packs containing 28 hard capsules in a wallet.
  • Unit packs containing 28 hard capsules (7 daily blisters, each containing 4 hard capsules) or 40 hard capsules (5 blisters, each containing 8 hard capsules).
  • Multipacks containing 112 (4 wallets of 28) hard capsules.
  • Multipacks containing 112 (4 packs of 28) hard capsules, 120 (3 packs of 40) hard capsules or 392 (14 packs of 28) hard capsules.

PA/Alu/PVC/Alu blisters:

  • Unit packs containing 28 hard capsules in a wallet.
  • Multipacks containing 112 (4 packs of 28) hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

Tasigna 50 mg hard capsules:

EU/1/07/422/015

Tasigna 200 mg hard capsules:

EU/1/07/422/001-004
EU/1/07/422/007-008
EU/1/07/422/011-012
EU/1/07/422/014

Date of first authorisation: 19 November 2007
Date of latest renewal: 19 November 2012

Drugs

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