SYMBICORT

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, 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 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 about Eformoterol

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC code Group title 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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 10015D, 10018G, 10024N, 12041R, 12042T, 12082X, 12089G, 12093L, 12100W, 12101X, 8625Y, 8750M, 8796Y
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502303901177310, 502303902173319, 502303903171311, 502316030030703, 502316030030803
Country: CA Health Products and Food Branch Identifier(s): 02245385, 02245386
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 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
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 4516-MEE-1218, 4547-MEE-0119, 4595-MEE-0219, 4800-MEE-0819
Country: EE Ravimiamet Identifier(s): 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
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 63956, 63958, 65044, 81115, 85232
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 000410, 000453, 000460, 000468, 009841, 010106, 439859
Country: FR Base de données publique des médicaments Identifier(s): 61237448, 64275087, 65082080, 66057945, 67916395
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 139589, 146206, 146209, 146212, 329267, 32943, 32947, 374443, 377394, 379974, 379976, 379978, 391061, 43741
Country: HK Department of Health Drug Office Identifier(s): 49175, 49176, 51625
Country: IE Health Products Regulatory Authority Identifier(s): 32963, 36903, 36910, 47865, 47910, 47917, 47918, 61572, 61591
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4434, 4536, 4774
Country: JP 医薬品医療機器総合機構 Identifier(s): 2290801G1029, 2290801G2025
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 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
Country: MT Medicines Authority Identifier(s): MA046/00901, MA046/00902, MA046/00903, MA046/00904, MA046/00905
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 310M2001
Country: NG Registered Drug Product Database Identifier(s): A4-7006, A4-7007
Country: NL Z-Index G-Standaard Identifier(s): 14642948, 14642964, 14744333
Country: NL Z-Index G-Standaard, PRK Identifier(s): 204730, 70335, 70343
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 10625, 13545, 13546, 14106, 9732, 9733
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100249392, 100249452, 100249469, 100367750
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): 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
Country: SG Health Sciences Authority Identifier(s): 11678P, 11681P, 12580P, 14961P, 14962P, 14963P, 14964P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 4833021, 4833022, 4833023
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699786520073, 8699786550087, 8699786550094, 8699786550100, 8699786550117, 8699786550124
Country: US FDA, National Drug Code Identifier(s): 0186-0370, 0186-0372

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