Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

10 mg

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10BX16, tirzepatide

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2022-09-22

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

Solution for injection in vial	0.5 ml
Tirzepatidas	10 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
111558	97671	1097671	flakonas	N1		Receptinis	EU/1/22/1685/022	Netiekiama	-	-	No	-	-
111809	97924	1097924	flakonas	N4		Receptinis	EU/1/22/1685/037	Netiekiama	-	-	No	-	-
111810	97925	1097925	flakonas	N12		Receptinis	EU/1/22/1685/038	Netiekiama	-	-	No	-	-
111811	97926	1097926	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/039	Netiekiama	-	-	No	-	-
111812	97927	1097927	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/040	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas