Scemblix

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

asciminib hydrochloride

Disponible depuis:

Novartis Europharm Limited

Code ATC:

L01EA06

DCI (Dénomination commune internationale):

asciminib

Groupe thérapeutique:

Antineoplastic agents

Domaine thérapeutique:

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

indications thérapeutiques:

Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

Descriptif du produit:

Revision: 3

Statut de autorisation:

Authorised

Date de l'autorisation:

2022-08-25

Notice patient

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Scemblix 20 mg film-coated tablets
Scemblix 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Scemblix 20 mg film-coated tablets
Each film-coated tablet contains 21.62 mg asciminib hydrochloride,
equivalent to 20 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 43 mg lactose monohydrate.
Scemblix 40 mg film-coated tablets
Each film-coated tablet contains 43.24 mg asciminib hydrochloride,
equivalent to 40 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Scemblix 20 mg film-coated tablets
Pale yellow, round, biconvex film-coated tablets with bevelled edges
of approximately 6 mm
diameter, debossed with company logo on one side and “20” on the
other side.
Scemblix 40 mg film-coated tablets
Violet white, round, biconvex film-coated tablets with bevelled edges
of approximately 8 mm
diameter, debossed with company logo on one side and “40” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Scemblix is indicated for the treatment of adult patients with
Philadelphia chromosome-positive
chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously
treated with two or more
tyrosine kinase inhibitors (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
diagnosis and treatment of patients
with leukaemia.
3
Posology
The recommended dose is 40 mg twice daily at approximately 12-hour
intervals.
_Missed dose_
If a dose is missed by less than 6 hours, it should be taken and the
next dose should be

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Scemblix 20 mg film-coated tablets
Scemblix 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Scemblix 20 mg film-coated tablets
Each film-coated tablet contains 21.62 mg asciminib hydrochloride,
equivalent to 20 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 43 mg lactose monohydrate.
Scemblix 40 mg film-coated tablets
Each film-coated tablet contains 43.24 mg asciminib hydrochloride,
equivalent to 40 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Scemblix 20 mg film-coated tablets
Pale yellow, round, biconvex film-coated tablets with bevelled edges
of approximately 6 mm
diameter, debossed with company logo on one side and “20” on the
other side.
Scemblix 40 mg film-coated tablets
Violet white, round, biconvex film-coated tablets with bevelled edges
of approximately 8 mm
diameter, debossed with company logo on one side and “40” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Scemblix is indicated for the treatment of adult patients with
Philadelphia chromosome-positive
chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously
treated with two or more
tyrosine kinase inhibitors (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
diagnosis and treatment of patients
with leukaemia.
3
Posology
The recommended dose is 40 mg twice daily at approximately 12-hour
intervals.
_Missed dose_
If a dose is missed by less than 6 hours, it should be taken and the
next dose should be