Sitagliptin/Metformin hydrochloride Grindeks

Medicinal product

(Invented) name

Sitagliptin/Metformin hydrochloride Grindeks

Active substance (s)

Sitagliptinas/Metformino hidrochloridas

Strength

50 mg/850 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

AS Grindeks, Latvija

Date of authorisation

2022-04-15

Date of renewal

Documents

4944_4945 Sitagliptin_Metformin HCL Grindeks PCS PL 2025 04 29.docx

4944_4945 Pakuotės lapelis 2025 04 29.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2115/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Sitagliptinas	50 mg
Metformino hidrochloridas	850 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
108504	94608	1094608	lizdinė plokštelė	N28		Receptinis	LT/1/22/4944/001	Netiekiama	-	-	No	-	-
108505	94609	1094609	lizdinė plokštelė	N56		Receptinis	LT/1/22/4944/002	Tiekiama	-	-	No	-	-
108506	94610	1094610	lizdinė plokštelė	N98		Receptinis	LT/1/22/4944/003	Netiekiama	-	-	No	-	-
110565	96675	1096675	lizdinė plokštelė	N196 (2x98)		Receptinis	LT/1/22/4944/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-15	Registruotas