APROVEL

This brand name is authorized in Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa

Active ingredients

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

1 Irbesartan UNII J0E2756Z7N - IRBESARTAN

Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. Read about Irbesartan

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
APROVEL Tablet	European Medicines Agency (EU)	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
C09CA04	Irbesartan	C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09C Angiotensin II antagonists, plain → C09CA Angiotensin II antagonists, plain
Discover more medicines within C09CA04

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): 502818805119313, 502818807111311, 576720090089417, 576720090089517
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00145632, 00145649, 00145709, 00215002, 00267335, 00267341, 00267720, 00926890, 01312262, 01312279, 02540344, 02766019, 02766195, 02766249, 02766284, 02766367, 03387117, 03913787, 04257730, 04388679, 04479181, 05548895, 05739187, 06839850, 06937156, 07746458, 07746487, 07746518, 09714149, 09760190, 10713178, 13784919, 16488357, 16747735, 16813461, 16813478, 16833417, 16876467, 16909103
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 27.743-06-07, 27.745-06-07
Country: EE	Ravimiamet	Identifier(s): 1034378, 1034389, 1034390, 1060467, 1060478, 1060489, 1060490, 1060502, 1060513, 1195646, 1195657, 1195668, 1212950, 1212961, 1212972, 1212983, 1212994, 1213007, 1213018, 1213029, 1213030, 1213041, 1213052, 1213063, 1308181, 1308192, 1308204, 1308215, 1308226, 1308237, 1308248, 1308259, 1308260
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 97046017, 97046022, 97046027
Country: FR	Base de données publique des médicaments	Identifier(s): 64522751, 64933635, 67481345
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 13555, 13558, 138284, 138286, 138288, 16309, 299603, 299605, 299607, 374291, 374293, 374295
Country: HK	Department of Health Drug Office	Identifier(s): 42891, 42892
Country: IE	Health Products Regulatory Authority	Identifier(s): 12053, 12064, 12077, 12100, 12118, 12124, 12125, 12142, 12193, 12209, 12210, 12242, 12258, 12266
Country: IT	Agenzia del Farmaco	Identifier(s): 033264045, 033264072
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004073, 1008037, 1008038, 1008039, 1010721, 1010722, 1010723, 1010724, 1010725, 1017611, 1017612, 1017613, 1027414, 1027415, 1027416, 1027417, 1027418, 1027419, 1027420, 1027421, 1027422, 1027423, 1027424, 1027425, 1027426, 1027427, 1027428, 1027429, 1027430, 1027431, 1027432, 1027433, 1027434, 1027435, 1027436, 1027437, 1027438, 1027439, 1027440
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 415M97
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 48798, 48801, 92606
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100000250, 100083230, 100084086, 100157997, 100158011, 100158028
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69390001, W69390002, W69390003, W69390004, W69390005, W69391001, W69391002, W69391003, W69391004, W69391005, W69392001, W69392002, W69392003, W69392004, W69392005, W69392006, W69392007, W69392008, W69393001, W69393002, W69393003, W69393004, W69393005, W69393006, W69393007, W69393008, W69394001, W69394002, W69394003, W69394004, W69394005, W69394006, W69394007, W69394008, W69395001, W69395002, W69395003, W69395004, W69395005
Country: SG	Health Sciences Authority	Identifier(s): 10861P, 10862P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 9263251, 9263252, 9263256, 9263257
Country: ZA	Health Products Regulatory Authority	Identifier(s): 31/7.1.3/0633, 31/7.1.3/0634