APROVEL

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

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 more about Irbesartan

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
APROVEL Tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	502818805119313, 502818807111311, 576720090089417, 576720090089517
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	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
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	27.743-06-07, 27.745-06-07
EE	Ravimiamet	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
ES	Centro de información online de medicamentos de la AEMPS	97046017, 97046022, 97046027
FR	Base de données publique des médicaments	64522751, 64933635, 67481345
GB	Medicines & Healthcare Products Regulatory Agency	13555, 13558, 138284, 138286, 138288, 16309, 299603, 299605, 299607, 374291, 374293, 374295
HK	Department of Health Drug Office	42891, 42892
IE	Health Products Regulatory Authority	12053, 12064, 12077, 12100, 12118, 12124, 12125, 12142, 12193, 12209, 12210, 12242, 12258, 12266
IT	Agenzia del Farmaco	033264045, 033264072
LT	Valstybinė vaistų kontrolės tarnyba	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
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	415M97
NG	Registered Drug Product Database	A4-7849, A4-7850
Switch country to Nigeria in order to find specific presentations of APROVEL
NL	Z-Index G-Standaard, PRK	48798, 48801, 92606
PL	Rejestru Produktów Leczniczych	100000250, 100083230, 100084086, 100157997, 100158011, 100158028
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	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
SG	Health Sciences Authority	10861P, 10862P
TN	Direction de la Pharmacie et du Médicament	9263251, 9263252, 9263256, 9263257
ZA	Health Products Regulatory Authority	31/7.1.3/0633, 31/7.1.3/0634