Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Nilotinib HCl monohydrate 165.45mg eqv Nilotinib
NOVARTIS (SINGAPORE) PTE LTD
L01XE08
150mg
CAPSULE
Nilotinib HCl monohydrate 165.45mg eqv Nilotinib 150mg
ORAL
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2011-05-11
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- Read the complete document
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 Read the complete document