Fivotta

Medicinal product

(Invented) name

Fivotta

Active substance (s)

Dapagliflozinas

Strength

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)

A10BK01, Dapagliflozin

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2026-05-20

Date of renewal

Documents

6030-31_pakuotes lapelis_2026-05-20.docx

6030-6031_Fivotta.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0986/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
120913	107021	1107021	lizdinė plokštelė	N30		Receptinis	LT/1/26/6031/001	Netiekiama	-	-	No	-	-
120914	107022	1107022	lizdinė plokštelė	N60		Receptinis	LT/1/26/6031/002	Netiekiama	-	-	No	-	-
120915	107023	1107023	lizdinė plokštelė	N90		Receptinis	LT/1/26/6031/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-05-20	Registruotas