Imatinib DOC Generici 100 mg, capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB

Beschikbaar vanaf:

DOC Generici S.r.l.

ATC-code:

L01XE01

INN (Algemene Internationale Benaming):

IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Imatinib

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MAGNESIUMSTEARAAT (E 470b); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2014-09-15

Bijsluiter

Proposed with grouping var.07 harmonization As
requested by MEB (25.01.17) keep the mark (*) and
the note in the SmPC, beside the patented GIST
indication in section 4.1, as long as the patent is in
place.
Common Technical Document
Imatinib (as mesilate), 100 mg
capsules
Page 1 of 8
1.3.1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB DOC GENERICI 100 MG CAPSULES
imatinib
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a medicine containing an active substance called
imatinib. This medicine works by
inhibiting the growth of abnormal cells in the diseases listed below.
These include some types of cancer.
IS A TREATMENT FOR ADULTS AND CHILDREN FOR:

CHRONIC MYELOID LEUKAEMIA (CML)
. Leukaemia is a cancer of white blood cells. These white
cells usually help the body to fight infection. Chronic myeloid
leukaemia is a form of leukaemia in
which certain abnormal white cells (named myeloid cells) start growing
out of control.
IMATINIB IS ALSO A TREATMENT FOR ADULTS FOR:

PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL).
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight
infection. Acute lymphoblasti

Productkenmerken

Proposed with grouping var.07 harmonization
As requested by MEB (25.01.17) keep the mark (*)
and the note in the SmPC, beside the patented GIST
indication in section 4.1, as long as the patent is in
place.
Common Technical Document
Imatinib (as mesilate), 100 mg
capsules
Page 1 of 32
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS - CORE
1
NAME OF THE MEDICINAL PRODUCT
Imatinib DOC Generici 100 mg, 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
Capsule.
Hard gelatin capsule (15.9 mm x 5.8 mm) with brown/orange coloured
body and cap. The cap is
imprinted with “I9AB 100” with black ink.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 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-PDGFRα rearrangement.
The effect of on the outcome of bone marrow transplantation
has not been determined.
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