Datolin

Medicinal product

(Invented) name

Datolin

Active substance (s)

Dapagliflozinas

Strength

5 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)

A10BK01, Dapagliflozin

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2026-06-04

Date of renewal

Documents

6041-6042-Datolin.docx

6041-42-pakuotes lapelis_2026-06-04.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3623/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
121102	107210	1107210	lizdinė plokštelė	N30		Receptinis	LT/1/26/6041/001	Netiekiama	-	-	No	-	-
121103	107211	1107211	lizdinė plokštelė	N60		Receptinis	LT/1/26/6041/002	Netiekiama	-	-	No	-	-
121104	107212	1107212	lizdinė plokštelė	N90		Receptinis	LT/1/26/6041/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-04	Registruotas