Edistride

Medicinal product

(Invented) name

Edistride

Active substance (s)

Dapagliflozinas

Strength

5 mg

Pharmaceutical form

dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BK01, Dapagliflozin

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2015-11-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Coated tablet	1 vnt.
Dapagliflozinas	5 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
64200	78660	1078660	lizdinė plokštelė	N14		Receptinis	EU/1/15/1052/001	Netiekiama	-	-	No	-	-
64201	78661	1078661	lizdinė plokštelė	N28		Receptinis	EU/1/15/1052/002	Netiekiama	-	-	No	-	-
64202	78662	1078662	lizdinė plokštelė	N98		Receptinis	EU/1/15/1052/003	Netiekiama	-	-	No	-	-
64203	78663	1078663	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1052/004	Netiekiama	-	-	No	-	-
64204	78664	1078664	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/15/1052/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-09	Registruotas