SEROQUEL

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

Active ingredients

The drug SEROQUEL contains one active pharmaceutical ingredient (API):

1
UNII 2S3PL1B6UJ - QUETIAPINE FUMARATE
 

Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.

 
Read more about Quetiapine

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SEROQUEL Film-coated tablet MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

ATC Group Classification
N05AH04 Quetiapine N Nervous system → N05 Psycholeptics → N05A Antipsychotics → N05AH Diazepines, oxazepines and thiazepines
Discover more medicines within N05AH04

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 5458G, 8456C, 8457D, 8458E, 8580N, 9202H, 9203J, 9204K, 9205L
BR Câmara de Regulação do Mercado de Medicamentos 502303701119211, 502303702115218, 502303703111216, 502303705114212, 502306001118312, 502306003110319, 502306006111316, 502306011113313
CA Health Products and Food Branch 02236951, 02236952, 02236953, 02244107, 02300184, 02300192, 02300206, 02300214, 02321513
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00948638, 00948650, 00948673, 00948704, 00948727, 01135021, 01135191, 01168144, 01168196, 01628717, 01840185, 02129726, 02129732, 02129755, 02129761, 02129778, 02129784, 02136212, 02136241, 02457991, 02458016, 03051334, 03272294, 03272302, 03422316, 03422322, 03422339, 03422345, 04171508, 04172809, 04172815, 04174139, 04174412, 04174725, 04174783, 04810316, 05124391, 05520081, 06081206, 06081212, 06846318, 06865089, 07387692, 09544753, 09948002, 11006431, 15896580, 15996689
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 22.681-1-03-06, 2353-MEE-0716, 2858-MEE-0617, 29337-08-10, 29340-08-10, 29341-08-10, 29342-08-10
EE Ravimiamet 1038406, 1038417, 1115086, 1120644, 1274576, 1274587, 1274598, 1274600, 1274611, 1274622
ES Centro de información online de medicamentos de la AEMPS 63054, 63055, 63056, 64436, 69645, 69646, 69647, 69648, 70859
FI Lääkealan turvallisuus- ja kehittämiskeskus 005296, 027933, 119385, 119419, 119430, 130013, 130021, 435651
GB Medicines & Healthcare Products Regulatory Agency 140254, 140258, 140261, 140266, 147069, 147071, 147077, 147079, 147083, 162422, 162424, 162428, 162430, 162432, 175933, 175935, 175939, 175945, 175949, 176899, 22142, 22155, 22166, 368956, 373456, 373577, 373690, 373702, 373733, 49892
HK Department of Health Drug Office 43711, 43712, 43713, 52580, 57715, 57716, 57717, 57718, 58348
HR Agencija za lijekove i medicinske proizvode HR-H-202528018, HR-H-204008507, HR-H-408184728, HR-H-461808155, HR-H-607016913, HR-H-789589749, HR-H-955743091
IE Health Products Regulatory Authority 29216, 31142, 45804, 45812, 45815, 45832, 45848, 45863, 45872, 45903, 46003, 46025, 46026, 46027, 46028, 66920, 66921, 66922, 66923, 66924
IL מִשְׂרַד הַבְּרִיאוּת 4129, 4130, 4131, 6025, 6437, 6438, 6439, 6440, 6938
IT Agenzia del Farmaco 032944011, 032944035, 032944050, 032944100, 032944112, 032944124, 032944136, 032944148, 032944151, 032944163
JP 医薬品医療機器総合機構 1179042C1023, 1179042F1020, 1179042F2026, 1179042F3022
LT Valstybinė vaistų kontrolės tarnyba 1003715, 1004899, 1004900, 1004901, 1004902, 1019931, 1019932, 1033323, 1055197
MT Medicines Authority MA046/02301, MA046/02302, MA046/02303, PI908/20301A
MX Comisión Federal para la Protección contra Riesgos Sanitarios 071M98, 113M2012
NL Z-Index G-Standaard, PRK 50741, 50768, 50776, 60283, 84182, 84190, 84204, 84212, 94757
NZ Medicines and Medical Devices Safety Authority 10012, 10013, 7736, 7737, 7738
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65167001, W65167002, W65167003, W65167004, W65167005, W65167006, W65167007, W65168001, W65168002, W65168003, W65168004, W65168005, W65168006, W65168007, W65169001, W65169002, W65169003, W65169004, W65169005, W65169006, W65169007, W65170001, W65170002, W65170003, W65170004, W65170005, W65170006, W65170007, W65171001, W65171002, W65171003, W65171004, W65171005, W65171006, W65171007
SG Health Sciences Authority 09766P, 09767P, 09771P, 13236P, 13502P, 13503P, 13504P, 13505P, 13919P
TN Direction de la Pharmacie et du Médicament 7973021, 7973022, 7973023, 7973024, 7973025, 7973026, 7973027, 7973028
TR İlaç ve Tıbbi Cihaz Kurumu 8699786090118, 8699786090125, 8699786092648, 8699786092655, 8699786092662, 8699786092679
US FDA, National Drug Code 0310-0271, 0310-0272, 0310-0274, 0310-0275, 0310-0278, 0310-0279, 0310-0280, 0310-0281, 0310-0282, 0310-0283, 0310-0284, 55289-187, 55289-447, 55289-872, 70518-2166, 70518-2424, 70518-2828
ZA Health Products Regulatory Authority 32/2.6.5/0589, 32/2.6.5/0590, 32/2.6.5/0591, 36/2.6.5/0070, 42/2.6.5/0573, 42/2.6.5/0574, 42/2.6.5/0575, 42/2.6.5/0576, 44/2.6.5/0973

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