SYMBICORT

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

Active ingredients

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

1	Budesonide UNII Q3OKS62Q6X - BUDESONIDE
	Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.
	Read more about Budesonide
2	Eformoterol UNII W34SHF8J2K - FORMOTEROL FUMARATE
	Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge.
	Read more about Eformoterol

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-7006	Inhalation solution	SYMBICORT 80/4.5MCG TURBUHALER INHALANT 80 mcg/Inhalation; 4.5 mcg/Inhalation X 60DOSES	45 RNW-PP-263042 SYMBICORT 80/4.5MCG TURBUHALER BUDESONIDE + FORMOTEROL FUMARATE BUDESONIDE 80MCG, FORMOTEROL FUMARATE 4.5MCG, EXCIPIENTS; LACTOSE MONOHYDRATE A4-7006 Drugs Imported Products X60DOSES Prescription Only Medicine (POM) 5/26/2022 ASTRAZENECA NIGERIA LIMITED, ALFRED OLAIYA STREET, AWUSE ESTATE IKEJA LAGOS 12719120 funmi.ogunwale@astrazeneca.com ASTRAZENECA AB, SE-15185, SODERTALJE ,SWEDEN, Sweden	06/07/2023
A4-7007	Inhalation solution	SYMBICORT 160/4.5MCG TURBUHALER INHALANT 160 mcg/Inhalation; 4.5 mcg/Inhalation X 60DOSES	44 RNW-PP-263045 SYMBICORT 160/4.5MCG TURBUHALER BUDESONIDE + FORMOTEROL FUMARATE BUDESONIDE 160MCG, FORMOTEROL FUMARATE 4.5MG, LACTOSE MONOHYDRATE 800MG A4-7007 Drugs Imported Products X60DOSES Prescription Only Medicine (POM) 5/26/2022 ASTRAZENECA NIGERIA LIMITED, ALFRED OLAIYA STREET, AWUSE ESTATE IKEJA LAGOS 12719120 funmi.ogunwale@astrazeneca.com ASTRAZENECA AB, SE-15185, SODERTALJE ,SWEDEN, Sweden	06/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SYMBICORT Inhalation powder	MPI, EU: SmPC	Health Products Regulatory Authority (IE)

Medicine classification

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

ATC Group		Classification
R03AK07	Formoterol and budesonide	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 R03AK07

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	10015D, 10018G, 10024N, 12041R, 12042T, 12082X, 12089G, 12093L, 12100W, 12101X, 8625Y, 8750M, 8796Y
BR	Câmara de Regulação do Mercado de Medicamentos	502303901177310, 502303902173319, 502303903171311, 502316030030703, 502316030030803
CA	Health Products and Food Branch	02245385, 02245386
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00017928, 00017934, 00434081, 00610922, 01433310, 01827641, 01828238, 02129198, 02521714, 02521743, 02848875, 02923542, 03109200, 03199634, 03652312, 03652625, 03652878, 03652890, 03811928, 03811934, 03864215, 04700125, 04700131, 04968193, 04968201, 04968218, 05370233, 05370262, 05374082, 05464922, 05481122, 05500428, 05500434, 05500440, 05548731, 06057107, 06195803, 06195849, 06468922, 06587147, 06628030, 06628076, 06706178, 06786912, 07227327, 07263458, 07293347, 07293353, 07371515, 07665984, 07771120, 07771137, 07771143, 07771166, 07771195, 07771203, 07799650, 07799667, 07799696, 08844393, 08844418, 08856924, 09000119, 09006398, 09012826, 09012832, 09166966, 09303630, 09304405, 09424233, 09651590, 09752687, 09775808, 10813796, 10813827, 10957704, 10964199, 10964207, 11057842, 11101939, 14227167, 14227173, 14227210, 15427247, 15568396, 16600162, 16600179, 16600185, 16610663, 16610686, 16612745, 16612811, 16697931, 17855906, 17855912
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	4516-MEE-1218, 4547-MEE-0119, 4595-MEE-0219, 4800-MEE-0819
EE	Ravimiamet	1013724, 1068443, 1072493, 1072505, 1156250, 1466535, 1466546, 1466557, 1466568, 1466579, 1466580, 1466591, 1466603, 1466670, 1466681, 1466692, 1466704, 1466715, 1466726, 1466737, 1466748, 1466861, 1466883, 1466906, 1466928, 1665604, 1784392, 1792931, 1792942, 1842814
ES	Centro de información online de medicamentos de la AEMPS	63956, 63958, 65044, 81115, 85232
FI	Lääkealan turvallisuus- ja kehittämiskeskus	000410, 000453, 000460, 000468, 009841, 010106, 439859
FR	Base de données publique des médicaments	61237448, 64275087, 65082080, 66057945, 67916395
GB	Medicines & Healthcare Products Regulatory Agency	139589, 146206, 146209, 146212, 329267, 32943, 32947, 374443, 377394, 379974, 379976, 379978, 391061, 43741
HK	Department of Health Drug Office	49175, 49176, 51625
HR	Agencija za lijekove i medicinske proizvode	HR-H-203679076, HR-H-228973738, HR-H-446429052, HR-H-680667236, HR-H-885448176
IE	Health Products Regulatory Authority	32963, 36903, 36910, 47865, 47910, 47917, 47918, 61572, 61591
IL	מִשְׂרַד הַבְּרִיאוּת	4434, 4536, 4774
JP	医薬品医療機器総合機構	2290801G1029, 2290801G2025
LT	Valstybinė vaistų kontrolės tarnyba	1003512, 1003736, 1004023, 1008008, 1008009, 1024448, 1060907, 1060908, 1060909, 1060910, 1060911, 1060912, 1060913, 1060914, 1060915, 1060916, 1060917, 1060918, 1060919, 1060920, 1060921, 1060922, 1060923, 1060924, 1060925, 1063142, 1074497, 1085572, 1090700, 1090701
MT	Medicines Authority	MA046/00901, MA046/00902, MA046/00903, MA046/00904, MA046/00905
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	310M2001
NG	Registered Drug Product Database	A4-7006, A4-7007
NL	Z-Index G-Standaard	14642948, 14642964, 14744333
NL	Z-Index G-Standaard, PRK	204730, 70335, 70343
NZ	Medicines and Medical Devices Safety Authority	10625, 13545, 13546, 14106, 9732, 9733
PL	Rejestru Produktów Leczniczych	100249392, 100249452, 100249469, 100367750
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W56426001, W56426002, W56426003, W56426004, W56426005, W56426006, W56426007, W56426008, W56426009, W56426010, W56427001, W56427002, W56427003, W56427004, W56427005, W56427006, W56427007, W56427008, W56427009, W56427010, W56428001, W56428002, W56428003, W56428004, W56428005, W62789001, W66886001, W66886002
SG	Health Sciences Authority	11678P, 11681P, 12580P, 14961P, 14962P, 14963P, 14964P
TN	Direction de la Pharmacie et du Médicament	4833021, 4833022, 4833023
TR	İlaç ve Tıbbi Cihaz Kurumu	8699786520073, 8699786550087, 8699786550094, 8699786550100, 8699786550117, 8699786550124
US	FDA, National Drug Code	0186-0370, 0186-0372