Rybelsus

Medicinal product

(Invented) name

Rybelsus

Active substance (s)

Semagliutidas

Strength

7 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

Rybelsus DHCP.pdf

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

Tablet	1 vnt.
Semagliutidas	7 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
103754	89856	1089856	lizdinė plokštelė	N30		Receptinis	EU/1/20/1430/005	Tiekiama	-	-	No	-	-
103755	89857	1089857	lizdinė plokštelė	N60		Receptinis	EU/1/20/1430/006	Netiekiama	-	-	No	-	-
103756	89858	1089858	lizdinė plokštelė	N90		Receptinis	EU/1/20/1430/007	Netiekiama	-	-	No	-	-
105459	91559	1091559	lizdinė plokštelė	N100		Receptinis	EU/1/20/1430/012	Netiekiama	-	-	No	-	-
107734	93839	1093839	lizdinė plokštelė	N10		Receptinis	EU/1/20/1430/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas