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
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. |
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. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
SYMBICORT Inhalation powder | Health Products Regulatory Authority (IE) | MPI, EU: SmPC |
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 |
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: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-203679076, HR-H-228973738, HR-H-446429052, HR-H-680667236, HR-H-885448176 |
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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