Rybelsus

Medicinal product

(Invented) name

Rybelsus

Active substance (s)

Semagliutidas

Strength

9 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BJ06, Semaglutide

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2020-04-03

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Semagliutidas	9 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
114429	100539	1100539	lizdinė plokštelė	N10		Receptinis	EU/1/20/1430/026	Netiekiama	-	-	No	-	-
114430	100540	1100540	lizdinė plokštelė	N30		Receptinis	EU/1/20/1430/027	Tiekiama	2025-10-21	-	No	-	-
114431	100541	1100541	lizdinė plokštelė	N60		Receptinis	EU/1/20/1430/028	Netiekiama	-	-	No	-	-
114432	100542	1100542	lizdinė plokštelė	N90		Receptinis	EU/1/20/1430/029	Netiekiama	-	-	No	-	-
114433	100543	1100543	lizdinė plokštelė	N100		Receptinis	EU/1/20/1430/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas