SYMBICORT

This brand name is authorized in United States. 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, Nigeria, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
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
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

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
Switch country to Nigeria in order to find specific presentations of SYMBICORT
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

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