INSPRA

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

Active ingredients

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

1
UNII 6995V82D0B - EPLERENONE
 

Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors. Eplerenone prevents the binding of aldosterone, a key hormone in the renin-angiotensin-aldosterone-system (RAAS), which is involved in the regulation of blood pressure and the pathophysiology of CV disease.

 
Read more about Eplerenone

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 INSPRA Film-coated tablet MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group Classification
C03DA04 Eplerenone C Cardiovascular system → C03 Diuretics → C03D Potassium-sparing agents → C03DA Aldosterone antagonists
Discover more medicines within C03DA04

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 8879H, 8880J
CA Health Products and Food Branch 02323052, 02323060
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00136780, 00136834, 00136946, 00137561, 01004951, 01004974, 01016871, 01016894, 01129262, 02949211, 02949228, 02949234, 02949286, 02949292, 03268909, 03268921, 03268950, 03269116, 03270355, 03270378, 03270409, 04511105, 04511111, 04511128, 04513682, 06108098, 06111315, 06111321, 06111344, 06489114, 07586799, 07586813, 07586859, 07770586, 09236684, 09236690, 09923982, 10783256, 10957673, 11149024, 11149030, 11230200, 11519722, 11709635, 13416050, 13416067, 13416073, 13416104, 13416110, 13416127, 14357119, 15376768, 15376774, 15376797, 15376805, 15568255, 15568261, 16812303, 17448064, 17602140
EE Ravimiamet 1206694, 1206830, 1206841, 1206852, 1206863, 1206874, 1206885, 1206896, 1206908, 1206919, 1206920, 1206931, 1206942, 1206953, 1206964, 1206975
ES Centro de información online de medicamentos de la AEMPS 66355, 66356
FI Lääkealan turvallisuus- ja kehittämiskeskus 018926, 018998
FR Base de données publique des médicaments 65681906, 66335558
GB Medicines & Healthcare Products Regulatory Agency 175669, 175671, 381408, 84774, 84799
HK Department of Health Drug Office 53030, 53031
HR Agencija za lijekove i medicinske proizvode HR-H-244093147, HR-H-730921224
IE Health Products Regulatory Authority 30507, 30542, 30557
IL מִשְׂרַד הַבְּרִיאוּת 4958, 4959
IT Agenzia del Farmaco 037298092, 037298217
LT Valstybinė vaistų kontrolės tarnyba 1021524, 1021525, 1021526, 1021527, 1021528, 1021529, 1021530, 1021531, 1021532, 1021533, 1021534, 1021535, 1021536, 1021537, 1021538, 1021539, 1024337, 1024338, 1024339, 1024340, 1024341, 1024342, 1024343, 1024344, 1024345, 1024346, 1033999, 1034000, 1061470, 1061471
MX Comisión Federal para la Protección contra Riesgos Sanitarios 268M2004
NL Z-Index G-Standaard, PRK 73431, 73458
NZ Medicines and Medical Devices Safety Authority 11534, 11536
PL Rejestru Produktów Leczniczych 100162343, 100162366
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W67260002, W67260004, W67260005, W67260006, W67260007, W67260008, W67260009, W67260010, W67260011, W67260012, W67260013, W67260014, W67261002, W67261004, W67261005, W67261006, W67261007, W67261008, W67261009, W67261010, W67261011, W67261012, W67261013, W67261014
SG Health Sciences Authority 13048P, 13049P
TR İlaç ve Tıbbi Cihaz Kurumu 8699532094001, 8699532094018
US FDA, National Drug Code 0025-1710, 0025-1720
ZA Health Products Regulatory Authority A39/6.4/0106, A39/6.4/0107

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