Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

7,5 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	7,5 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
111557	97670	1097670	flakonas	N1		Receptinis	EU/1/22/1685/021	Netiekiama	-	-	No	-	-
111805	97920	1097920	flakonas	N4		Receptinis	EU/1/22/1685/033	Netiekiama	-	-	No	-	-
111806	97921	1097921	flakonas	N12		Receptinis	EU/1/22/1685/034	Netiekiama	-	-	No	-	-
111807	97922	1097922	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/035	Netiekiama	-	-	No	-	-
111808	97923	1097923	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas