Ozempic

Medicinal product

(Invented) name

Ozempic

Active substance (s)

Semagliutidas

Strength

1,34 mg/ml

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

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	1 ml
Semagliutidas	1,34 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
98971	85075	1085075	užpildytas švirkštiklis	1,5 ml ir 6 vienkartinės adatos N1		Receptinis	EU/1/17/1251/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-31	Išregistruotas
2018-02-08	Registruotas