Imatinib Actavis

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
05-07-2022
Public Assessment Report Public Assessment Report (PAR)
05-07-2022

Active ingredient:

imatinib

Available from:

Actavis Group PTC ehf

ATC code:

L01EA01

INN (International Name):

imatinib

Therapeutic group:

Protein kinase inhibitors, Antineoplastic agents

Therapeutic area:

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

Therapeutic indications:

Imatinib Actavis is indicated for the treatment of: , 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;, paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with Ph+ CML in blast crisis;, adult 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 treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. , Efectul de imatinib pe rezultatul de transplantul de măduvă osoasă nu a fost determinată. Imatinib Actavis is indicated for: , In adult and paediatric patients, the effectiveness of imatinib 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 DFSP. Experiența cu imatinib la pacienții cu MDS/MPD asociate cu genei FCDP-re-aranjamente este foarte limitat. Nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

Product summary:

Revision: 13

Authorization status:

retrasă

Authorization date:

2013-04-17

Patient Information leaflet

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
Medicamentul nu mai este autorizat
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Imatinib Actavis 50 mg capsule
Imatinib Actavis 100 mg capsule
Imatinib Actavis 400 mg capsule
2.
COMPOZI
Ţ
IA CALITATIV
Ă
Ş
I CANTITATIVĂ
Imatinib Actavis 50 mg capsule
Fiecare capsulă conţine imatinib 50 mg (sub formă de mesilat).
Imatinib Actavis 100 mg capsule
Fiecare capsulă conţine imatinib 100 mg (sub formă de mesilat).
Imatinib Actavis 400 mg capsule
Fiecare capsulă conţine imatinib 400 mg (sub formă de mesilat).
Pentru lista tuturor excipienţilor, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Capsulă
Imatinib Actavis 50 mg capsule
Capsulă de dimensiune 3, cu cap de culoare galben deschis şi corp de
culoare galben deschis, marcată pe
corp cu “50 mg” cu cerneală neagră.
Imatinib Actavis 100 mg capsule
Capsulă de dimensiune 1, cu cap de culoare portocaliu deschis şi
corp de culoare portocaliu deschis,
marcată pe corp cu “100 mg” cu cerneală neagră.
Imatinib Actavis 400 mg capsule
Capsulă de dimensiune 00, cu capac și corp de culoare portocalie
opacă, marcată cu “400 mg” cu cerneală
neagră.
4.
DATE CLINICE
4.1
INDICAŢII TERAPEUTICE
Imatinib Actavis este indicat pentru tratamentul
-
pacienţilor copii şi adolescenţi diagnosticaţi recent cu leucemie
granulocitară cronică (LGC) cu
cromozom Philadelphia (bcr-abl) pozitiv (Ph+), la care transplantul de
măduvă osoasă nu este
considerat un tratament de primă linie.
-
pacienţilor copii şi adolescenţi cu LGC Ph+ în fază cronică,
după eşecul tratamentului cu alfa-
interferon sau în faza accelerată sau în criza blastică.
-
pacienţilor adulţi cu LGC Ph+ în criză blastică.
-
pacienţilor adulţi, adolescenţi şi copii diagnosticaţi recent cu
leucemie limfoblastică acută cu
cromozom Philadelphia pozitiv (LLA Ph+), asociat cu chimioterapie.
-
pacienţilor adulţi cu LLA Ph+ recidivantă sau refractară, în
monoterapie.
Medicamentul nu mai este autorizat
3
-
pacienţilor adulţi cu 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
Medicamentul nu mai este autorizat
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Imatinib Actavis 50 mg capsule
Imatinib Actavis 100 mg capsule
Imatinib Actavis 400 mg capsule
2.
COMPOZI
Ţ
IA CALITATIV
Ă
Ş
I CANTITATIVĂ
Imatinib Actavis 50 mg capsule
Fiecare capsulă conţine imatinib 50 mg (sub formă de mesilat).
Imatinib Actavis 100 mg capsule
Fiecare capsulă conţine imatinib 100 mg (sub formă de mesilat).
Imatinib Actavis 400 mg capsule
Fiecare capsulă conţine imatinib 400 mg (sub formă de mesilat).
Pentru lista tuturor excipienţilor, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Capsulă
Imatinib Actavis 50 mg capsule
Capsulă de dimensiune 3, cu cap de culoare galben deschis şi corp de
culoare galben deschis, marcată pe
corp cu “50 mg” cu cerneală neagră.
Imatinib Actavis 100 mg capsule
Capsulă de dimensiune 1, cu cap de culoare portocaliu deschis şi
corp de culoare portocaliu deschis,
marcată pe corp cu “100 mg” cu cerneală neagră.
Imatinib Actavis 400 mg capsule
Capsulă de dimensiune 00, cu capac și corp de culoare portocalie
opacă, marcată cu “400 mg” cu cerneală
neagră.
4.
DATE CLINICE
4.1
INDICAŢII TERAPEUTICE
Imatinib Actavis este indicat pentru tratamentul
-
pacienţilor copii şi adolescenţi diagnosticaţi recent cu leucemie
granulocitară cronică (LGC) cu
cromozom Philadelphia (bcr-abl) pozitiv (Ph+), la care transplantul de
măduvă osoasă nu este
considerat un tratament de primă linie.
-
pacienţilor copii şi adolescenţi cu LGC Ph+ în fază cronică,
după eşecul tratamentului cu alfa-
interferon sau în faza accelerată sau în criza blastică.
-
pacienţilor adulţi cu LGC Ph+ în criză blastică.
-
pacienţilor adulţi, adolescenţi şi copii diagnosticaţi recent cu
leucemie limfoblastică acută cu
cromozom Philadelphia pozitiv (LLA Ph+), asociat cu chimioterapie.
-
pacienţilor adulţi cu LLA Ph+ recidivantă sau refractară, în
monoterapie.
Medicamentul nu mai este autorizat
3
-
pacienţilor adulţi cu 
                                
                                Read the complete document

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Active ingredient imatinib

imatinib

ATC code L01EA01

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Marketed by Actavis Group PTC ehf

Actavis Group PTC ehf

INN (International Name) imatinib

imatinib

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