Sitagliptin/Metformin hydrochloride SUN

Medicinal product

(Invented) name

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)

ATC code (s)

A10BD07, Metformin and sitagliptin

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2023-03-31

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Sitagliptinas	50 mg
Metformino hidrochloridas	850 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
110825	96936	1096936	buteliukas	N28	Receptinis	EU/1/23/1720/001	Netiekiama	-	-	No	-	-
110826	96937	1096937	buteliukas	N56	Receptinis	EU/1/23/1720/002	Netiekiama	-	-	No	-	-
110827	96938	1096938	buteliukas	N200	Receptinis	EU/1/23/1720/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-31	Registruotas