Daplemsen

Medicinal product

(Invented) name

Daplemsen

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

MSN Labs Europe Limited, Malta

Date of authorisation

2026-08-11

Date of renewal

Documents

6113-14_Daplemsen.docx

6113-14_pakuotes lapelis_2026-08-11.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6213/001/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
121858	107966	1107966	lizdinė plokštelė	N14		Receptinis	LT/1/26/6113/001	Netiekiama	-	-	No	-	-
121859	107967	1107967	lizdinė plokštelė	N28		Receptinis	LT/1/26/6113/002	Netiekiama	-	-	No	-	-
121860	107968	1107968	lizdinė plokštelė	N98		Receptinis	LT/1/26/6113/003	Netiekiama	-	-	No	-	-
121861	107969	1107969	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/26/6113/004	Netiekiama	-	-	No	-	-
121862	107970	1107970	dalomoji lizdinė plokštelė	N90×1		Receptinis	LT/1/26/6113/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-08-11	Registruotas