Glivec

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

imatinib

Tillgänglig från:

Novartis Europharm Limited

ATC-kod:

L01EA01

INN (International namn):

imatinib

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome

Terapeutiska indikationer:

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-PDGFRa 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 surgery. , In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS / MPD, on haematological response rates in HES / CEL and on objective response rates in adult patients with unresectable and / or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS / MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

Produktsammanfattning:

Revision: 46

Bemyndigande status:

Authorised

Tillstånd datum:

2001-11-07

Bipacksedel

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Glivec 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
White to yellow powder in an orange to greyish-orange opaque capsule,
marked “NVR SI”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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

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 fo

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Glivec 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
White to yellow powder in an orange to greyish-orange opaque capsule,
marked “NVR SI”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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

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 fo