Tasigna Capsule 200mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NILOTINIB HYDROCHLORIDE MONOHYDRATE 220.6 mg EQV NILOTINIB ANHYDROUS

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

L01XE08

Dosage:

200mg

Pharmaceutical form:

CAPSULE

Composition:

NILOTINIB HYDROCHLORIDE MONOHYDRATE 220.6 mg EQV NILOTINIB ANHYDROUS 200mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2008-07-17

Patient Information leaflet

TASIGNA


Antineoplastic agents - Protein-tyrosine kinase inhibitor 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Hard capsules 
150 MG HARD CAPSULES 
White  to  yellowish  powder  in  red  opaque  hard  gelatin  capsules,  size  1  with  black  axial 
imprint “NVR/BCR”. 
200 MG HARD CAPSULES 
White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial 
imprint “NVR/TKI”. 
ACTIVE SUBSTANCE 
150 MG HARD CAPSULES 
Each capsule contains 150 mg nilotinib base (as hydrochloride,
monohydrate). 
200 MG HARD CAPSULES 
Each capsule contains 200 mg nilotinib base (as hydrochloride,
monohydrate) 
ACTIVE MOIETY 
Nilotinib 
EXCIPIENTS 
150 MG HARD CAPSULES 
Capsule  content:  Lactose  monohydrate;  Crospovidone;  Poloxamer  188;  Silica  colloidal, 
anhydrous/Colloidal silicon dioxide; Magnesium stearate 
Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, red (E 172), Iron oxide, yellow 
(E 172) 
Printing ink: Iron oxide, black (E 172) 
200 MG HARD CAPSULES 
Capsule  content:  Lactose  monohydrate;  Crospovidone;  Poloxamer  188;  Silica  colloidal, 
anhydrous/Colloidal silicon dioxide; Magnesium stearate 
Capsule shell: Gelatin; Titanium dioxide (E
171); Iron oxide, yellow (E 172) 
Printing ink: Iron oxide, red (E 172),
Iron oxide, black (E172) 
Pharmaceutical formulations may vary between countries. 

INDICATIONS 
Tasigna hard capsules are indicated for the: 

  treatment  of  adult  patients  with  newly  diagnosed  Philadelphia  chromosome  positive 
chronic  myeloid  leukemia  (Ph+  CML)  in  chronic  phase.  The  effectiveness  of  Tasigna  is 
based on major molecular response and cytogenetic response rates. The study is ongoing 
and further data
will be required to determine long-

Summary of Product characteristics

Tasigna May 2020.SINv1 Page 1 of 42
TASIGNA

Antineoplastic agents - Protein-tyrosine kinase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules
50 MG HARD CAPSULES
White to yellowish powder in gelatin capsule with red opaque cap and
light yellow opaque body,
size 4 with black radial imprint “NVR/ABL” on cap
150 MG HARD CAPSULES
White
to
yellowish powder
in
red opaque hard gelatin
capsules,
size 1
with
black
axial
imprint “NVR/BCR”.
200 MG HARD CAPSULES
White to yellowish powder in light yellow opaque hard gelatin
capsules, size 0 with red axial
imprint “NVR/TKI”.
ACTIVE SUBSTANCE
50 MG HARD CAPSULES
One hard capsule contains 50 mg nilotinib base (as hydrochloride
monohydrate)
150 MG HARD CAPSULES
Each capsule contains 150 mg nilotinib base (as hydrochloride,
monohydrate).
200 MG HARD CAPSULES
Each capsule contains 200 mg nilotinib base (as hydrochloride,
monohydrate)
EXCIPIENTS
50 MG HARD CAPSULES
Capsule content: Lactose monohydrate; Crospovidone; Poloxamer; Silica
colloidal,
anhydrous/Colloidal silicon dioxide; Magnesium stearate
Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, red (E
172), Iron oxide, yellow (E
172)
Printing ink: Shellac; Iron oxide, black (E 172); Propylene glycol;
Ammonium hydroxide
150 MG HARD CAPSULES
Capsule content: Lactose monohydrate; Crospovidone; Poloxamer; Silica
colloidal,
anhydrous/Colloidal silicon dioxide; Magnesium stearate
Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, red (E
172), Iron oxide, yellow (E
172)
Printing ink: Shellac; Iron oxide, black (E 172); n-Butyl alcohol;
Propylene glycol; Dehydrated
ethanol; Isopropyl alcohol; Ammonium hydroxide
Tasigna May 2020.SINv1 Page 2 of 42
200 MG HARD CAPSULES
Capsule content: Lactose monohydrate; Crospovidone; Poloxamer; Silica
colloidal,
anhydrous/Colloidal silicon dioxide; Magnesium stearate
Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, yellow
(E 172)
Printing ink: Shellac; Dehydrated alcohol; Isopropyl alcohol; Butyl
alcohol; Propylene glycol;
Strong