Rybelsus

Medicinal product

(Invented) name

Rybelsus

Active substance (s)

Semagliutidas

Strength

14 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	14 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
103757	89859	1089859	lizdinė plokštelė	N30		Receptinis	EU/1/20/1430/008	Tiekiama	-	-	No	-	-
103758	89860	1089860	lizdinė plokštelė	N60		Receptinis	EU/1/20/1430/009	Netiekiama	-	-	No	-	-
103759	89861	1089861	lizdinė plokštelė	N90		Receptinis	EU/1/20/1430/010	Netiekiama	-	-	No	-	-
105460	91560	1091560	lizdinė plokštelė	N100		Receptinis	EU/1/20/1430/013	Netiekiama	-	-	No	-	-
107735	93840	1093840	lizdinė plokštelė	N10		Receptinis	EU/1/20/1430/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas