Dasatinib Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dasatinib

Available from:

Accord Healthcare S.L.U.

ATC code:

L01EA02

INN (International Name):

dasatinib (anhydrous)

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Therapeutic indications:

Dasatinib Accord is indicated for the treatment of adult patients with:• Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.Dasatinib Accord is indicated for the treatment of paediatric patients with:• newly diagnosed Ph+ ALL in combination with chemotherapy.

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2022-03-24

Patient Information leaflet

49
B. PACKAGE LEAFLET
Medicinal product no longer authorised
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
DASATINIB ACCORD 20 MG FILM-COATED TABLETS
DASATINIB ACCORD 50 MG FILM-COATED TABLETS
DASATINIB ACCORD 70 MG FILM-COATED TABLETS
DASATINIB ACCORD 80 MG FILM-COATED TABLETS
DASATINIB ACCORD 100 MG FILM-COATED TABLETS
DASATINIB ACCORD 140 MG FILM-COATED TABLETS
dasatinib
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dasatinib Accord is and what it is used for
2.
What you need to know before you take Dasatinib Accord
3.
How to take Dasatinib Accord
4.
Possible side effects
5.
How to store Dasatinib Accord
6.
Contents of the pack and other information
1.
WHAT DASATINIB ACCORD IS AND WHAT IT IS USED FOR
Dasatinib Accord contains the active substance dasatinib. This
medicine is used to treat Philadelphia
chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL). It is
used in adults who are not
benefiting from previous therapies, as well as being combined with
other cancer medicines in
adolescents and children from 1 year of age with newly diagnosed Ph+
ALL. In people with ALL,
white cells called lymphocytes multiply too quickly and live too long.
Dasatinib Accord inhibits the
growth of these leukaemic cells.
If you have any questions about how Dasatinib Accord works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DASATINIB ACCORD
_ _
DO NOT TAKE DASATINIB ACCORD
-
if you are
ALLERGIC
to dasatinib or any of the other ingredients of

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dasatinib Accord 20 mg film-coated tablets
Dasatinib Accord 50 mg film-coated tablets
Dasatinib Accord 70 mg film-coated tablets
Dasatinib Accord 80 mg film-coated tablets
Dasatinib Accord 100 mg film-coated tablets
Dasatinib Accord 140 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dasatinib Accord 20 mg film-coated tablets
Each film-coated tablet contains 20 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 27 mg of lactose (as monohydrate).
Dasatinib Accord 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 67.5 mg of lactose (as monohydrate).
Dasatinib Accord 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 94.5 mg of lactose (as monohydrate).
Dasatinib Accord 80 mg film-coated tablets
Each film-coated tablet contains 80 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 108 mg of lactose (as monohydrate).
Dasatinib Accord 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 135.0 mg of lactose (as monohydrate).
Dasatinib Accord 140 mg film-coated tablets
Each film-coated tablet contains 140 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 189 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dasatinib Accord 20 mg film-coated tablets
Medicinal product no longer authorised
3
White to off-white, round, 5.6 mm of diameter, coated tablets debossed
on one side with "DAS" and
"20" on the other side.
Dasatinib Accord 50 mg film-coated tablets
White to off-white, oval, 5.7 x 10.6 mm, coated tablets debossed on
one side with "DAS" and "50" on
the other