Sitagliptin/Metformin Zentiva

Medicinal product

(Invented) name

Sitagliptin/Metformin Zentiva

Active substance (s)

Sitagliptinas/Metformino hidrochloridas

Strength

50 mg/1000 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BD07, Metformin and sitagliptin

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2024-09-09

Date of renewal

Documents

5558_5559 Pakuotės lapelis 2025 05 16.docx

5558_5559 Sitagliptin_Metformin Zentiva PCS PL 2025 05 16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1210/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Sitagliptinas	50 mg
Metformino hidrochloridas	1000 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
114879	100984	1100984	lizdinė plokštelė	N28		Receptinis	LT/1/24/5559/001	Netiekiama	-	-	No	-	-
114880	100985	1100985	lizdinė plokštelė	N56		Receptinis	LT/1/24/5559/002	Netiekiama	-	-	No	-	-
114881	100986	1100986	lizdinė plokštelė	N60		Receptinis	LT/1/24/5559/003	Netiekiama	-	-	No	-	-
114882	100987	1100987	lizdinė plokštelė	N196		Receptinis	LT/1/24/5559/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-09	Registruotas