Qtern

Medicinal product

(Invented) name

Qtern

Active substance (s)

Saksagliptinas/Dapagliflozinas

Strength

5 mg/10 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)

A10BD21, Saxagliptin and dapagliflozin

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2016-07-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Saksagliptinas	5 mg
Dapagliflozinas	10 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
66240	80763	1080763	lizdinė plokštelė	N14 (kalendorinė)		Receptinis	EU/1/16/1108/001	Netiekiama	-	-	No	-	-
66241	80764	1080764	lizdinė plokštelė	N28 (kalendorinė)		Receptinis	EU/1/16/1108/002	Netiekiama	-	-	No	-	-
66242	80765	1080765	lizdinė plokštelė	N98 (kalendorinė)		Receptinis	EU/1/16/1108/003	Netiekiama	-	-	No	-	-
66243	80766	1080766	lizdinė plokštelė	N30		Receptinis	EU/1/16/1108/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-15	Registruotas