Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

15 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	15 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
111560	97673	1097673	flakonas	N1		Receptinis	EU/1/22/1685/024	Netiekiama	-	-	No	-	-
111817	97932	1097932	flakonas	N4		Receptinis	EU/1/22/1685/045	Netiekiama	-	-	No	-	-
111818	97933	1097933	flakonas	N12		Receptinis	EU/1/22/1685/046	Netiekiama	-	-	No	-	-
111819	97934	1097934	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/047	Netiekiama	-	-	No	-	-
111820	97935	1097935	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/048	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas