IMBRUVICA 140 MG TABLETS

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

IBRUTINIB

Tilgængelig fra:

J-C HEALTH CARE LTD

ATC-kode:

L01XE27

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

IBRUTINIB 140 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

CILAG AG, SWITZERLAND

Terapeutisk område:

IBRUTINIB

Terapeutiske indikationer:

• Mantle Cell Lymphoma:Imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma :Imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)• Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) with 17p deletion:Imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) with 17p deletion.• Waldenström’s MacroglobulinemiaImbruvica is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).• Marginal Zone LymphomaIMBRUVICA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.• Chronic Graft versus Host DiseaseIMBRUVICA is indicated for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Autorisation dato:

2021-06-22

Produktets egenskaber

Page 1 of 56
Imbruvica_Capsules_Tablets_SmPC_Dec2023_ref_USPI_May2022, EU SmPC
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FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
IMBRUVICA 140mg Capsules
IMBRUVICA 140mg TABLETS
IMBRUVICA 280mg TABLETS
IMBRUVICA 420mg TABLETS
IMBRUVICA 560mg TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 140 mg of
ibrutinib
Tablets:
IMBRUVICA 140mg
TABLETS
IMBRUVICA 280mg
TABLETS
IMBRUVICA 420mg
TABLETS
IMBRUVICA 560mg
TABLETS
Ibrutinib 140mg
Ibrutinib 280 mg
Ibrutinib 420mg
Ibrutinib 560mg
3
PHARMACEUTICAL FORM
Capsules; size 0, white opaque hard gelatin capsule with black
printing "ibr 140 mg", containing off-white to
white powder.
Tablets:
140 mg tablets: Yellow green to green round tablets debossed with
“ibr” on one side and
“140” on the other side.
280 mg tablets: Purple oblong tablets debossed with “ibr” on one
side and “280” on the
other side.
420 mg tablets: Yellow green to green oblong tablets debossed with
“ibr” on one side and
“420” on the other side.
560 mg tablets: Yellow to orange oblong tablets debossed with
“ibr” on one side and
“560” on the other side.
4
INDICATIONS AND USAGE
4.1
Mantle Cell Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with mantle
cell lymphoma (MCL) who have
received at least one prior therapy.
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Imbruvica_Capsules_Tablets_SmPC_Dec2023_ref_USPI_May2022, EU SmPC
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4.2
CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
IMBRUVICA is indicated for the treatment of adult patients with
chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL).
4.3
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p
deletion
IMBRUVICA is indicated for the treatment of adult patients with
chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL) with 17p deletion.
4.4
Waldenström’s Macroglobulinemia
IMBRUVICA is indicated for the treatment of adult patients with
Waldenström’s macroglobulinemia (WM).
4.5 Marginal Zone Lymphoma
IMBRUVICA is