Rybelsus

Medicinal product

(Invented) name

Rybelsus

Active substance (s)

Semagliutidas

Strength

3 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	3 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
103750	89852	1089852	lizdinė plokštelė	N10		Receptinis	EU/1/20/1430/001	Netiekiama	-	-	No	-	-
103751	89853	1089853	lizdinė plokštelė	N30		Receptinis	EU/1/20/1430/002	Tiekiama	-	-	No	-	-
103752	89854	1089854	lizdinė plokštelė	N60		Receptinis	EU/1/20/1430/003	Netiekiama	-	-	No	-	-
103753	89855	1089855	lizdinė plokštelė	N90		Receptinis	EU/1/20/1430/004	Netiekiama	-	-	No	-	-
105458	91558	1091558	lizdinė plokštelė	N100		Receptinis	EU/1/20/1430/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas