RASILEZ

This brand name is authorized in Austria, Canada, Croatia, Cyprus, Estonia, France, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, South Africa, Spain, UK.

Active ingredients

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

1
UNII C8A0P8G029 - ALISKIREN HEMIFUMARATE
 

Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin. By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.

 
Read more about Aliskiren

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RASILEZ Film-coated 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
C09XA02 Aliskiren C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09X Other agents acting on the renin-angiotensin system → C09XA Renin-inhibitors
Discover more medicines within C09XA02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02302063, 02302071
EE Ravimiamet 1307023, 1307034, 1307045, 1307056, 1307067, 1307078, 1307089, 1307090, 1307102, 1307113, 1307124, 1307135, 1307146, 1307157, 1307168, 1307179, 1307180, 1307191, 1307203, 1307214
ES Centro de información online de medicamentos de la AEMPS 07405022, 07405032
FR Base de données publique des médicaments 61195604, 61280428
GB Medicines & Healthcare Products Regulatory Agency 119610, 119618, 175904, 178849, 180663, 186092, 186094, 375325, 375328
HK Department of Health Drug Office 60309, 60310
IE Health Products Regulatory Authority 68210, 68211, 68250, 68255, 68280, 68281
IT Agenzia del Farmaco 038243010, 038243022, 038243034, 038243046, 038243059, 038243061, 038243073, 038243085, 038243097, 038243109, 038243111, 038243123, 038243135, 038243147, 038243150, 038243162, 038243174, 038243186, 038243198, 038243200, 038243212, 038243224, 038243236, 038243248, 038243251, 038243263, 038243275, 038243287, 038243299, 038243301, 038243313, 038243325, 038243337, 038243349, 038243352, 038243364, 038243376, 038243388, 038243390, 038243402
JP 医薬品医療機器総合機構 2149047F1028
LT Valstybinė vaistų kontrolės tarnyba 1030623, 1030624, 1030625, 1030626, 1030627, 1030628, 1030629, 1030630, 1030631, 1030632, 1030633, 1030634, 1030635, 1030636, 1030637, 1030638, 1030639, 1030640, 1030641, 1030642, 1056696, 1056697, 1056698, 1056699, 1056700, 1056701, 1056702, 1056703, 1056704, 1056705, 1056706, 1056707, 1056708, 1056709, 1056710, 1056711, 1056712, 1056713, 1056714, 1056715
NL Z-Index G-Standaard, PRK 85065, 85073
PL Rejestru Produktów Leczniczych 100147757, 100178657
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W52241001, W52241002, W52241003, W52241004, W52241005, W52241006, W52241007, W52241008, W52241009, W52241010, W52242001, W52242002, W52242003, W52242004, W52242005, W52242006, W52242007, W52242008, W52242009, W52242010
ZA Health Products Regulatory Authority 41/7.1.3/0971, 41/7.1.3/0972

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