Edistride

Medicinal product

(Invented) name

Edistride

Active substance (s)

Dapagliflozinas

Strength

10 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	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
64205	78665	1078665	lizdinė plokštelė	N14		Receptinis	EU/1/15/1052/006	Netiekiama	-	-	No	-	-
64206	78666	1078666	lizdinė plokštelė	N28		Receptinis	EU/1/15/1052/007	Netiekiama	-	-	No	-	-
64207	78667	1078667	lizdinė plokštelė	N98		Receptinis	EU/1/15/1052/008	Netiekiama	-	-	No	-	-
64208	78668	1078668	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1052/009	Netiekiama	-	-	No	-	-
64209	78669	1078669	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/15/1052/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-09	Registruotas