Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

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	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
111556	97669	1097669	flakonas	N1		Receptinis	EU/1/22/1685/020	Netiekiama	-	-	No	-	-
111801	97916	1097916	flakonas	N4		Receptinis	EU/1/22/1685/029	Netiekiama	-	-	No	-	-
111802	97917	1097917	flakonas	N12		Receptinis	EU/1/22/1685/030	Netiekiama	-	-	No	-	-
111803	97918	1097918	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/031	Tiekiama	-	-	No	-	-
111804	97919	1097919	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/032	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas