Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE
1units Units
Recipharm HC Limited
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 Read the complete document
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: +44 (0) 1223 424 444_ 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 Read the complete document