DYMISTA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

Active ingredients

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

1 Azelastine
UNII 0L591QR10I - AZELASTINE HYDROCHLORIDE

Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

Read about Azelastine
2 Fluticasone
UNII O2GMZ0LF5W - FLUTICASONE PROPIONATE

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

Read about Fluticasone

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
DYMISTA Nasal Spray Medicines & Healthcare Products Regulatory Agency (GB) 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
R01AD58 R Respiratory system → R01 Nasal preparations → R01A Decongestants and other nasal preparations for topical use → R01AD Corticosteroids
Discover more medicines within R01AD58

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 541519030014517, 541519030014617, 543915080000305
Country: CA Health Products and Food Branch Identifier(s): 02432889
Country: EE Ravimiamet Identifier(s): 1544543, 1544554, 1544565, 1544576, 1870006
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 3400927563119, 3400927563119IP, 76618
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 167770, 428910
Country: FR Base de données publique des médicaments Identifier(s): 60830011
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 219770, 387236
Country: HK Department of Health Drug Office Identifier(s): 63517
Country: IE Health Products Regulatory Authority Identifier(s): 18302, 18354
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1062990, 1069388, 1069389, 1069390, 1087702, 1090233, 1091785, 1092605, 1093209
Country: MT Medicines Authority Identifier(s): MA1507/00701, PI770/16101A
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 056M2015
Country: NL Z-Index G-Standaard, PRK Identifier(s): 122939
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 17585
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100302531, 100403232
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68695001, W68695002, W68695003, W68695004
Country: SG Health Sciences Authority Identifier(s): 15255P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8698856540409, 8698856540515
Country: US FDA, National Drug Code Identifier(s): 0037-0245

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