Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

2,5 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	2,5 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
111555	97668	1097668	flakonas	N1		Receptinis	EU/1/22/1685/019	Netiekiama	-	-	No	-	-
111797	97912	1097912	flakonas	N4		Receptinis	EU/1/22/1685/025	Netiekiama	-	-	No	-	-
111798	97913	1097913	flakonas	N12		Receptinis	EU/1/22/1685/026	Netiekiama	-	-	No	-	-
111799	97914	1097914	flakonas	N4 (4×1)		Receptinis	EU/1/22/1685/027	Netiekiama	-	-	No	-	-
111800	97915	1097915	flakonas	N12 (12×1)		Receptinis	EU/1/22/1685/028	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas