Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

12,5 mg

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

Solution for injection in pre-filled pen	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
109507	95612	1095612	užpildytas švirkštiklis	N2		Receptinis	EU/1/22/1685/013	Netiekiama	-	-	No	-	-
109508	95613	1095613	užpildytas švirkštiklis	N4		Receptinis	EU/1/22/1685/014	Netiekiama	-	-	No	-	-
109509	95614	1095614	užpildytas švirkštiklis	N12 (3×4)		Receptinis	EU/1/22/1685/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas