Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

12,5 mg/dozėje

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

Dozėje (0,6 ml) tirpalo yra:	0.6 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
113439	99557	1099557	užpildytas švirkštiklis	N1 (KwikPen, 4 dozės)		Receptinis	EU/1/22/1685/057	Netiekiama	-	-	No	-	-
113440	99558	1099558	užpildytas švirkštiklis	N3 (KwikPen, po 4 dozes)		Receptinis	EU/1/22/1685/058	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas