Glivec tablets film-coated

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

imatinib (imatinib mesylate)

Saadav alates:

Novartis Pharma Stein AG

ATC kood:

L01XE01

INN (Rahvusvaheline Nimetus):

imatinib (imatinib mesylate)

Annus:

400mg

Ravimvorm:

tablets film-coated

Ühikuid pakis:

(30/3x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2015-12-23

Toote omadused

1
ANNEX I
BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT
2
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 receive adjuvant treatment.
•
the treatment of adult patients with unresectable dermatofibrosarcoma
protuberans (DFSP)
and adult patients with recurrent and/or metastatic DFSP who are not
eligible for surg