COSOPT

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, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Tunisia, UK.

Active ingredients

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

1
UNII QZO5366EW7 - DORZOLAMIDE HYDROCHLORIDE
 

Dorzolamide is a potent inhibitor of human carbonic anhydrase II. Following topical ocular administration, dorzolamide reduces elevated intra-ocular pressure, whether or not associated with glaucoma.

 
Read more about Dorzolamide
2
UNII P8Y54F701R - TIMOLOL MALEATE
 

Timolol is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol reduces intra-ocular pressure, whether or not this is associated with glaucoma.

 
Read more about Timolol

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 COSOPT Eye drops, solution 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
S01ED51 Timolol, combinations S Sensory organs → S01 Ophthalmologicals → S01E Antiglaucoma preparations and miotics → S01ED Beta blocking agents
Discover more medicines within S01ED51

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 5542Q, 8567X
BR Câmara de Regulação do Mercado de Medicamentos 556717100001217, 556717100001317
CA Health Products and Food Branch 02240113, 02258692
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00120336, 00120342, 00572794, 00745622, 01035578, 01035590, 01035615, 03397133, 03404927, 04131199, 04131207, 04131213, 04347278, 04347284, 04347290, 05026211, 05026292, 05026300, 05495414, 05495420, 06434544, 06474733, 06924544, 06964437, 06964466, 09900604, 09900610, 10535995, 10536026, 10993611, 11006425, 11340880, 11340897, 11380081, 11522380, 11557390, 11597432, 11599402, 11613987, 12421936, 12490860, 12490937, 12559221, 14300148, 14300154, 15266324, 16147136, 16503631, 16503648, 16503654, 16617814, 17176683, 17176944, 17176950, 17586381, 17586398, 17669635, 17669664
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 22.583-1-02-06
EE Ravimiamet 1039799, 1483882, 1741733, 1774324, 1774346
ES Centro de información online de medicamentos de la AEMPS 3400934806384, 62535, 83389
FI Lääkealan turvallisuus- ja kehittämiskeskus 061951, 114447, 440064
FR Base de données publique des médicaments 62782316
GB Medicines & Healthcare Products Regulatory Agency 109293, 14900, 182248, 198697, 198699, 198735, 365731, 373921, 376271, 378122, 381273, 392396, 393599
HK Department of Health Drug Office 46578, 65674
HR Agencija za lijekove i medicinske proizvode HR-H-149562311, HR-H-438170589
IE Health Products Regulatory Authority 18510, 18525, 18530, 18533, 73764
IL מִשְׂרַד הַבְּרִיאוּת 3827
IT Agenzia del Farmaco 034242103
JP 医薬品医療機器総合機構 1319819Q1020, 1319819Q2026
LT Valstybinė vaistų kontrolės tarnyba 1003292, 1055301, 1055883, 1057508, 1063170, 1063171, 1068712, 1082390, 1084658, 1084659, 1084660, 1086370, 1086371, 1086372
MT Medicines Authority AA1068/00301
MX Comisión Federal para la Protección contra Riesgos Sanitarios 078M98
NL Z-Index G-Standaard 14235463
NL Z-Index G-Standaard, PRK 134155, 134163
PL Rejestru Produktów Leczniczych 100089391, 100248955, 100389354
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W57438001, W57438002, W57438003, W57438004, W57438005, W57438006, W62674001, W62674002, W65460001, W65460002, W65460003
SG Health Sciences Authority 11643P, 15435P
TN Direction de la Pharmacie et du Médicament 18583011, 5963142
US FDA, National Drug Code 17478-604, 17478-605
ZA Health Products Regulatory Authority 32/15.4/0525

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