Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

12,5 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	12,5 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
111559	97672	1097672	flakonas	N1		Receptinis	EU/1/22/1685/023	Netiekiama	-	-	No	-	-
111813	97928	1097928	flakonas	N4		Receptinis	EU/1/22/1685/041	Netiekiama	-	-	No	-	-
111814	97929	1097929	flakonas	N12		Receptinis	EU/1/22/1685/042	Netiekiama	-	-	No	-	-
111815	97930	1097930	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/043	Netiekiama	-	-	No	-	-
111816	97931	1097931	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/044	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas