Ozempic

Medicinal product

(Invented) name

Ozempic

Active substance (s)

Semagliutidas

Strength

2 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

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

2018-02-08

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

Kiekvienoje dozėje (0,74 ml) yra	0.74 ml
Semagliutidas	2 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
107843	93948	1093948	užpildytas švirkštiklis	3 ml N1 (4 dozės ir 4 adatos)		Receptinis	EU/1/17/1251/010	Netiekiama	-	-	No	-	-
107844	93949	1093949	užpildytas švirkštiklis	3 ml N3 (12 dozių ir 12 adatų)		Receptinis	EU/1/17/1251/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-08	Registruotas