PRODUCT DETAIL

Amirap HCT 5 mg/5 mg/12,5 mg tvrdé kapsuly

Code

2561E

MA number

58/0309/22-S

Product Form:

cps dur 10x5 mg/5 mg/12,5 mg (blis.PA/Al/PVC/Al)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Mutual recognition procedure

MAH, country:

Sandoz Pharmaceuticals d.d., Slovenia

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:

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