INSPRA

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

Active ingredients

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

1 Eplerenone 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 about Eplerenone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
INSPRA Film-coated tablet	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
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)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 8879H, 8880J
Country: CA	Health Products and Food Branch	Identifier(s): 02323052, 02323060
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 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
Country: EE	Ravimiamet	Identifier(s): 1206694, 1206830, 1206841, 1206852, 1206863, 1206874, 1206885, 1206896, 1206908, 1206919, 1206920, 1206931, 1206942, 1206953, 1206964, 1206975
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 66355, 66356
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 018926, 018998
Country: FR	Base de données publique des médicaments	Identifier(s): 65681906, 66335558
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 175669, 175671, 381408, 84774, 84799
Country: HK	Department of Health Drug Office	Identifier(s): 53030, 53031
Country: IE	Health Products Regulatory Authority	Identifier(s): 30507, 30542, 30557
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4958, 4959
Country: IT	Agenzia del Farmaco	Identifier(s): 037298092, 037298217
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 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
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 268M2004
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 73431, 73458
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11534, 11536
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100162343, 100162366
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67260002, W67260004, W67260005, W67260006, W67260007, W67260008, W67260009, W67260010, W67260011, W67260012, W67260013, W67260014, W67261002, W67261004, W67261005, W67261006, W67261007, W67261008, W67261009, W67261010, W67261011, W67261012, W67261013, W67261014
Country: SG	Health Sciences Authority	Identifier(s): 13048P, 13049P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699532094001, 8699532094018
Country: US	FDA, National Drug Code	Identifier(s): 0025-1710, 0025-1720
Country: ZA	Health Products Regulatory Authority	Identifier(s): A39/6.4/0106, A39/6.4/0107