Roxatenz-inda tablets film-coated

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

perindopril (perindopril tert-butylamine), indapamide, rosuvastatin (rosuvastatin calcium)

Dostupné z:

KRKA d.d.

ATC kód:

C10BX13

INN (Medzinárodný Name):

perindopril (perindopril tert-butylamine), indapamide, rosuvastatin (rosuvastatin calcium)

Dávkovanie:

4mg+ 1,25mg+ 20mg

Forma lieku:

tablets film-coated

Počet v balení:

(30/3x10/) in blister

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2023-03-10

Súhrn charakteristických

1.3.1
Perindopril + Indapamide + Rosuvastatin
SPC, Labeling and Package Leaflet
AM
SmPCPIL159917_1
02.12.2020 – Updated: 02.12.2020
Page 1 of 31
1.
NAME OF THE MEDICINAL PRODUCT
Roxatenz-inda 4 mg/1.25 mg/10 mg film-coated tablets
Roxatenz-inda 4 mg/1.25 mg/20 mg film-coated tablets
Roxatenz-inda 8 mg/2.5 mg/10 mg film-coated tablets
Roxatenz-inda 8 mg/2.5 mg/20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roxatenz-inda 4 mg/1.25 mg/10 mg film-coated tablets
Each film-coated tablet contains 4.000 mg perindopril tert-butylamine,
1.250 mg indapamide and
10.000 mg rosuvastatin (as rosuvastatin calcium).
Roxatenz-inda 4 mg/1.25 mg/20 mg film-coated tablets
Each film-coated tablet contains 4.000 mg perindopril tert-butylamine,
1.250 mg indapamide and
20.000 mg rosuvastatin (as rosuvastatin calcium).
Roxatenz-inda 8 mg/2.5 mg/10 mg film-coated tablets
Each film-coated tablet contains 8.000 mg perindopril tert-butylamine,
2.500 mg indapamide and
10.000 mg rosuvastatin (as rosuvastatin calcium).
Roxatenz-inda 8 mg/2.5 mg/20 mg film-coated tablets
Each film-coated tablet contains 8.000 mg perindopril tert-butylamine,
2.500 mg indapamide and
20.000 mg rosuvastatin (as rosuvastatin calcium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
film-coated tablet (tablet)
Roxatenz-inda 4 mg/1.25 mg/10 mg film-coated tablets
Reddish-brown, round, slightly biconvex film-coated tablets with
bevelled edges, engraved with mark
PIR1 on one side of the tablet.
Roxatenz-inda 4 mg/1.25 mg/20 mg film-coated tablets
Off-pink, round, slightly biconvex film-coated tablets with bevelled
edges, engraved with mark PIR2
on one side of the tablet.
Roxatenz-inda 8 mg/2.5 mg/10 mg film-coated tablets
Light pink, round, slightly biconvex film-coated tablets with bevelled
edges, engraved with mark PIR3
on one side of the tablet.
Roxatenz-inda 8 mg/2.5 mg/20 mg film-coated tablets
Pale pinkish-brown, round, slightly biconvex film-coated tablets with
bevelled edges, engraved with
mark PIR4 on one side of