Vildagliptin/Metformin hydrochloride Accord

Medicinal product

(Invented) name

Vildagliptin/Metformin hydrochloride Accord

Active substance (s)

Vildagliptinas/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)

A10BD08, Metformin and vildagliptin

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-03-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Vildagliptinas	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
108360	94464	1094464	lizdinė plokštelė	N30		Receptinis	EU/1/21/1611/001	Netiekiama	-	-	No	-	-
108361	94465	1094465	lizdinė plokštelė	N60		Receptinis	EU/1/21/1611/002	Netiekiama	-	-	No	-	-
109596	95702	1095702	lizdinė plokštelė	N180 (3×60)		Receptinis	EU/1/21/1611/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-24	Registruotas