ATECTURA BREEZHALER INHALATION POWDER HARD CAPSULE 150 MCG 320 MCG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Indacaterol acetate equivalent to Indacaterol; Mometasone furoate

Διαθέσιμο από:

NOVARTIS (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

R03AK14

Φαρμακοτεχνική μορφή:

POWDER, METERED

Σύνθεση:

Indacaterol acetate equivalent to Indacaterol 150 mcg; Mometasone furoate 320 mcg

Οδός χορήγησης:

RESPIRATORY (INHALATION)

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Novartis Pharma Stein AG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2021-04-07

Αρχείο Π.Χ.Π.

Atectura Jun 2020.SINv1
Page 1 of 22
TRADENAME(S)
ATECTURA
®
BREEZHALER
®
(indacaterol/mometasone furoate) 150/80 micrograms inhalation
powder, hard capsules
ATECTURA
®
BREEZHALER
®
(indacaterol/mometasone furoate) 150/160 micrograms inhalation
powder, hard capsules
ATECTURA
®
BREEZHALER
®
(indacaterol/mometasone furoate) 150/320 micrograms inhalation
powder, hard capsules
1
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Indacaterol/mometasone furoate 150/80 micrograms, inhalation powder,
hard capsules.
Capsules with natural transparent (uncolored) cap and body containing
a white to practically white
powder, with the product code “IM150-80” printed in blue on the
body and the
printed in blue
on the cap.
Indacaterol/mometasone furoate 150/160 micrograms, inhalation powder,
hard capsules.
Capsules with natural transparent (uncolored) cap and body containing
a white to practically white
powder, with the product code “M150-160” printed in grey on the
body and the
printed in grey
on the cap.
Indacaterol/mometasone furoate 150/320 micrograms, inhalation powder,
hard capsules.
Capsules with natural transparent (uncolored) cap and body containing
a white to practically white
powder, with the product code “IM150-320” printed in black on the
body and the
printed in
black on the cap.
ACTIVE SUBSTANCE(S)
Each capsule of Atectura Breezhaler 150/80 micrograms, contains 173
micrograms of indacaterol
acetate equivalent to 150 micrograms of indacaterol and 80 micrograms
of mometasone furoate.
Each capsule of Atectura Breezhaler 150/160 micrograms, contains 173
micrograms of indacaterol
acetate equivalent to 150 micrograms of indacaterol and 160 micrograms
of mometasone furoate.
Each capsule of Atectura Breezhaler 150/320 micrograms, contains 173
micrograms of indacaterol
acetate equivalent to 150 micrograms of indacaterol and 320 micrograms
of mometasone furoate
The delivered dose of Atectura Breezhaler 150/80 micrograms (the dose
that leaves the mouthpiece
of the inhaler) is equivalent to 125 micrograms ind