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PRODUCT DETAIL

Amirap HCT 5 mg/5 mg/25 mg tvrdé kapsuly

Code 2569E
MA number 58/0310/22-S
Product Form: cps dur 20x5 mg/5 mg/25 mg (blis.PA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C09 AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09B ACE INHIBITORS, COMBINATIONS
C09BX ACE inhibitors, other combinations
C09BX03 Ramipril, amlodipine and hydrochlorothiazide
Shelf life: 24
Container: blister PA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10b fixed combination application
MA issued: 03.01.2023
Validity: 03.01.2028
MA renewed: Renewal application submitted
PIL: PIL_Amirap HCT_01/2023.pdf  
SPC: SPC_Amirap HCT_01/2023.pdf  
Safety feature Yes
Data update: 10.01.2023
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