ALVOTINIB FILM COATED TABLETS 400MG

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Imatinib mesilate 478.0mg eqv. Imatinib

Disponible des:

LOTUS INTERNATIONAL PTE. LTD.

Codi ATC:

L01EA01

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Imatinib mesilate 478.0mg eqv. Imatinib 400 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

Remedica Ltd (Buildings 5 &10)

Estat d'Autorització:

ACTIVE

Data d'autorització:

2018-02-28

Fitxa tècnica

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1.
NAME OF THE MEDICINAL PRODUCT
ALVOTINIB 100 mg film-coated tablets
ALVOTINIB 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg film-coated tablets:
Each film-coated tablet contains 100 mg imatinib (as imatinib
mesilate).
400 mg film-coated tablets:
Each film-coated tablet contains 400 mg imatinib (as imatinib
mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
100 mg film-coated tablet:
Dark yellow to brownish-orange, round shaped, film-coated tablets of
10.1 mm (± 5%) diameter with
a break-line on one side and ‘100’ on the other side. The tablet
can be divided into equal doses.
400 mg film-coated tablets:
Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets,
21.6 mm long & 10.6mm wide
(± 5%) with a break-line on one side and ‘400’ on the other side.
The tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib is indicated for the
•
treatment of adult and paediatric patients with newly diagnosed
Philadelphia chromosome
positive chronic myeloid leukaemia (Ph+ CML) (for paediatric use see
section 4.2).
•
treatment of adult and paediatric patients with Ph+ CML in blast
crisis, accelerated phase, or in
chronic phase after failure of interferon-alpha therapy (for
paediatric use see section 4.2).
•
treatment of paediatric patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy.
•
treatment
of
adult
patients
with
Kit+
(CD117)
unresectable
and/or
metastatic
malignant
gastrointestinal stromal tumours (GIST).
•
adjuvant treatment of adult patients following complete gross
resection of Kit+ GIST.
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The effectiveness of imatinib is based on overall haematological and
cytogenetic response rates and
progression-free survival in CML, and on haematological and
cytogenetic response rates in relapsed or
refracto