Flutiform 125 microgram5 microgram per actuation pressurised inhalation suspension

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE

Boleh didapati daripada:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

Recipharm HC Limited

Risalah maklumat

Variation _(_
_MiV-N1, MiV-N2_
_)_
Date received:
_18 May 2022_
Date completed:
Prepared by
Product Name:
Flutiform 125 microgram/5 microgram per actuation pressurised
inhalation,
suspension
Call/Reference/Reg No.: 72056 / 201311202012A / MAL14125107ACZ
Manufacturer:
Recipharm HC Limited
Licensed Holder:
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
SEC
REMARKS
REPLY FROM MPSB
D4
Kindly update the Rimup/PIL serial number
of Bahasa Melayu and English as NPRA
(R1/2) 18052022/133
Please find revised D4:
D4 Flutiform BM_Mac2022_clean_upd
D4 Flutiform Eng_Mac2022_clean_upd

Ciri produk

R01107
720x200mm (CPRO-1-54) (L) V2
z
_ITEM DESCRIPTION:_
_MANUFACTURER / PACKER:_
_CREATED BY:_
_DATE CREATED:_
_VERSION:_
_POR NO.:_
COLOUR(S):
NON-PRINTING COLOURS
PINK
BLUE
PURPLE
BUFF
_PACKAGI NG _
_ARTWORK _
_TEAM_
_Bard Pharmaceuticals Ltd._
_Cambridge Science Park, Milton Road, _
_Cambridge CB4 0GW, UK_
_Tel: [phone]_
CG
31 MAR 2022
1
V11-2019
_PREFIXES_
N/A
_ITEM CODE 2:_
N/A
_DIMENSIONS FOLDED:_
40x200mm
_DIMENSIONS:_
720X200mm
_SECURITY CODE NO.:_
801
_SECURITY CODE TYPE:_
Pharmacode
_PATTERN REPEAT (MM):_
N/A
_UNWIND NO.:_
N/A
_DRAWING NO.:_
N/A
_PMS NO.:_
N/A
_TEMPLATE NO.:_
720x200mm (CPRO-1-54) (L) V2
FLUTIFORM INH 50-5MCG 125-5MCG 250-
10MCG PIL MY BN R01107
RECIPHARM
(FLUTIFORM)
12224
Black
PMS 280
PMS 1505
MINIMUM FONT SIZE:
7pt
FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1
FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1
31/03/2022 12:51
31/03/2022 12:51
1 NAME OF THE MEDICINAL PRODUCT
FLUTIFORM
®
50 microgram/5 microgram, 125 microgram/5 microgram
and 250 microgram/10 microgram per actuation pressurised
inhalation, suspensions.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
•
50 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate. This is equivalent to a delivered
dose (ex-actuator) of approximately 46 microgram of fluticasone
propionate/4.5 microgram of formoterol fumarate dihydrate.
•
125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate. This is equivalent to a delivered
dose (ex-actuator) of approximately 115 microgram of fluticasone
propionate/4.5 microgram of formoterol fumarate dihydrate.
•
250 micrograms of fluticasone propionate and 10 micrograms of
formoterol fumarate dihydrate. This is equivalent to a delivered
dose (ex-actuator) of approximately 230 microgram of fluticasone
propionate/9.0 microgram of formoterol fumarate dihydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inha