Mekinist

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

trametinib

Διαθέσιμο από:

Novartis Europharm Limited

Φαρμακολογική κατηγορία (ATC):

L01EE01

INN (Διεθνής Όνομα):

trametinib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Melanoma

Θεραπευτικές ενδείξεις:

MelanomaTrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).Adjuvant treatment of melanomaTrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.Non-small cell lung cancer (NSCLC)Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

Περίληψη προϊόντος:

Revision: 29

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-06-30

Φύλλο οδηγιών χρήσης

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mekinist 0.5 mg film-coated tablets
Mekinist 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mekinist 0.5 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 0.5 mg of trametinib.
Mekinist 2 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 2 mg of trametinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Mekinist 0.5 mg film-coated tablets
Yellow, modified oval, biconvex, film-coated tablets, approximately
5.0 x 9.0 mm, with the company
logo debossed on one face and “TT” on the opposing face.
Mekinist 2 mg film-coated tablets
Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with
the company logo debossed
on one face and “LL” on the opposing face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
Trametinib as monotherapy or in combination with dabrafenib is
indicated for the treatment of adult
patients with unresectable or metastatic melanoma with a BRAF V600
mutation (see sections 4.4 and
5.1).
Trametinib monotherapy has not demonstrated clinical activity in
patients who have progressed on a
prior BRAF inhibitor therapy (see section 5.1).
Adjuvant treatment of melanoma
Trametinib in combination with dabrafenib is indicated for the
adjuvant treatment of adult patients
with Stage III melanoma with a BRAF V600 mutation, following complete
resection.
Non-small cell lung cancer (NSCLC)
Trametinib in combination with dabrafenib is indicated for the
treatment of adult patients with
advanced non-small cell lung cancer with a BRAF V600 mutation.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with trametinib should only be initiated and supervised by a
physician experienced in the
administration of anti-cancer medicinal products.
Before taking trametinib, patients must have confirmation of BRAF V600
mutation using a validated
tes

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mekinist 0.5 mg film-coated tablets
Mekinist 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mekinist 0.5 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 0.5 mg of trametinib.
Mekinist 2 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 2 mg of trametinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Mekinist 0.5 mg film-coated tablets
Yellow, modified oval, biconvex, film-coated tablets, approximately
5.0 x 9.0 mm, with the company
logo debossed on one face and “TT” on the opposing face.
Mekinist 2 mg film-coated tablets
Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with
the company logo debossed
on one face and “LL” on the opposing face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
Trametinib as monotherapy or in combination with dabrafenib is
indicated for the treatment of adult
patients with unresectable or metastatic melanoma with a BRAF V600
mutation (see sections 4.4 and
5.1).
Trametinib monotherapy has not demonstrated clinical activity in
patients who have progressed on a
prior BRAF inhibitor therapy (see section 5.1).
Adjuvant treatment of melanoma
Trametinib in combination with dabrafenib is indicated for the
adjuvant treatment of adult patients
with Stage III melanoma with a BRAF V600 mutation, following complete
resection.
Non-small cell lung cancer (NSCLC)
Trametinib in combination with dabrafenib is indicated for the
treatment of adult patients with
advanced non-small cell lung cancer with a BRAF V600 mutation.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with trametinib should only be initiated and supervised by a
physician experienced in the
administration of anti-cancer medicinal products.
Before taking trametinib, patients must have confirmation of BRAF V600
mutation using a validated
tes