SERETIDE

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug SERETIDE contains a combination of these active pharmaceutical ingredients (APIs):

1	Salmeterol UNII 6EW8Q962A5 - SALMETEROL XINAFOATE
	Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist. These pharmacological properties of salmeterol offer more effective protection against histamine-induced bronchoconstriction and produce a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.
	Read more about Salmeterol
2	Fluticasone UNII O2GMZ0LF5W - FLUTICASONE PROPIONATE
	Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.
	Read more about Fluticasone

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-3323	Inhalation powder	SERETIDE 50MCG/250MCG DISKUS INHALATION POWDER PWD 250 mcg/Metered-Dose; 50 mcg/Metered-Dose 160	SERETIDE 50MCG/250MCG DISKUS INHALATION POWDER SALMETEROL AND FLUTICASONE PROPIONATE (Active Ingredients - Salmeterol (as xinafonate) 72.5µg & Fluticasone propionate 250µg) (Other ingredients- Lactose Monohydrate - 12.5mg) Apr-23 Drugs Imported Products 160 Prescription Only Medicine (POM) 02/03/2020 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 delphine.u.onyeaso@gsk.com GlaxoSmithKline LLC,1011 North Arendell Avenue,Zebulon ,North Carolina USA, GlaxoSmithKline LLC,1011 North Arendell Avenue ,Zebulon,North Carolina USA, United States	06/07/2023
04-6850	Inhalation powder	SERETIDE PWD 125 mcg; 25 mcg 1 X 120 actuations	25 RNW-PP-310050 SERETIDE 25MCG SALMETEROL/ 125MCG FLUTICASONE PROPIONATE Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 125 micrograms of fluticasone propionate Apr-50 Drugs Imported Products 1120actuations POM 1 2/1/2023 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 delphine.u.onyeaso@gsk.com GLAXO WELLCOME PRODUCTION, ZONE INDUSTRIELLE No 2, 23, RUE LAVOISIER 27000 EVREUSX FRANCE, France	25/05/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SERETIDE Inhaler	MPI, EU: SmPC	Medicines and Medical Devices Safety Authority (NZ)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
R03AK06	Salmeterol and fluticasone	R Respiratory system → R03 Drugs for obstructive airway diseases → R03A Adrenergics, inhalants → R03AK Adrenergics and other drugs for obstructive airway diseases
Discover more medicines within R03AK06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	8430Q, 8431R, 8432T, 8517G, 8518H, 8519J
BR	Câmara de Regulação do Mercado de Medicamentos	510607001177311, 510607002173318, 510607003171319, 510607004176314, 510607005172312, 510607006179310, 510611801174313, 510611802170311
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	06815849, 06815884, 06815921, 11175518, 15655988, 15655994
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1919-MEE-0316, 1984-MEE-0416, 29725-04-11, 29726-04-11, 29727-04-11, 7241-MEE-0522, 7479-MEE-0922
EE	Ravimiamet	1037595, 1037607, 1107335, 1107346, 1107357, 1153167, 1528185, 1528196, 1528208, 1711370, 1711392, 1711415, 1711426, 1711448, 1711460, 1711471, 1711493, 1711516
ES	Centro de información online de medicamentos de la AEMPS	62667, 62668, 62669, 63796, 63797, 63798
FI	Lääkealan turvallisuus- ja kehittämiskeskus	003870, 003948, 003959, 034978, 034987, 034996, 552612, 552620, 552646
FR	Base de données publique des médicaments	60569419, 61073237, 61572165, 64461896, 64587838, 67546191, 69505268
GB	Medicines & Healthcare Products Regulatory Agency	139976, 139985, 146742, 146748, 162412, 162414, 162416, 162445, 181859, 186115, 28300, 28308, 28310, 31870, 31873, 31884, 374433, 374435, 374437, 374441, 377023, 377025, 377027, 379966, 379969
HK	Department of Health Drug Office	44734, 44735, 44736, 48128, 48129, 48130
HR	Agencija za lijekove i medicinske proizvode	HR-H-251056275, HR-H-491933173, HR-H-513256189, HR-H-562619185, HR-H-572113579
IE	Health Products Regulatory Authority	45311, 45378, 45622, 45644, 45699, 53413, 54830, 56603, 60025, 60039, 60044, 72803, 72871, 72880, 72882
IL	מִשְׂרַד הַבְּרִיאוּת	4126, 4127, 4128
IT	Agenzia del Farmaco	034371043, 034371056, 034371068, 034371106, 034371118, 034371120
LT	Valstybinė vaistų kontrolės tarnyba	1002834, 1002835, 1002836, 1003487, 1003497, 1003498, 1003841, 1058265, 1058268, 1073216, 1073217
MT	Medicines Authority	MA192/00901, MA192/00902, MA192/00903, MA192/00905, PI1438/07701A, PI1438/07702A, PI908/21701A, PI908/21702A, PI908/21703A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	018M2001, 340M99
NG	Registered Drug Product Database	04-3323, 04-6850, B4-9735
NL	Z-Index G-Standaard	14254166, 14254174, 14254182, 14642786, 14642794, 14642808
NL	Z-Index G-Standaard, PRK	62510, 62529, 62537, 64955, 64963, 64971
NZ	Medicines and Medical Devices Safety Authority	8417, 8418, 8419, 9639, 9640, 9641
PL	Rejestru Produktów Leczniczych	100097404, 100097410, 100097427, 100104989, 100104995, 100105003
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65108001, W65108002, W65108003, W65108004, W65108005, W65109001, W65109002, W65109003, W65109004, W65109005, W65110001, W65110002, W65110003, W65110004, W65110005, W65217001, W65218001
SG	Health Sciences Authority	11030P, 11031P, 11032P, 11529P, 11530P, 11531P
TN	Direction de la Pharmacie et du Médicament	5163101, 5163102, 5163103, 5163111
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522523078, 8699522523085, 8699522553242, 8699522553259, 8699522553266
ZA	Health Products Regulatory Authority	33/21.5.4/0413, 33/21.5.4/0414, 33/21.5.4/0415, 35/21.5.4/0411, 35/21.5.4/0412, 35/21.5.4/0413