Glivec tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

imatinib (imatinib mesylate)

Available from:

Lek Pharmaceuticals d.d.

ATC code:

L01EA01

INN (International Name):

imatinib (imatinib mesylate)

Dosage:

100mg

Pharmaceutical form:

tablets film-coated

Units in package:

(60/6x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-05-21

Summary of Product characteristics

1
ANNEX I
BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions.
1.
NAME OF MEDICAL PRODUCT
GLIVEC
®
100 mg and 400 mg Film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_active substance:_
imatinib;
1 tablet contains imatinib mesylate equivalent to imatinib - 100 or
400 mg;
_excipients:_
For a complete list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL DATA
4.1 INDICATIONS.
Glivec is indicated for the treatment of
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl)
positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow
transplantation is
not considered as the first line of treatment.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with
platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
•
adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic
leukaemia (CEL) with FIP1L1-PDGFR
α
rearrangement.
The effect of Glivec on the outcome of bone marrow transplantation has
not been determined.
Glivec is indicated for
•
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic
malignant gastrointestinal stromal tumours (GIST).
•
the adjuvant treatment of adult patients who are at significant risk
of relapse following
resection of Kit (CD117)-positive GIST. Patients who have a low or
very low risk of
recurrence should not recei