Mounjaro

Medicinal product

(Invented) name

Mounjaro

Active substance (s)

Tirzepatidas

Strength

2,5 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	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
109494	95600	1095600	užpildytas švirkštiklis	N2		Receptinis	EU/1/22/1685/001	Netiekiama	-	-	No	-	-
109495	95601	1095601	užpildytas švirkštiklis	N4		Receptinis	EU/1/22/1685/002	Netiekiama	-	-	No	-	-
109496	95602	1095602	užpildytas švirkštiklis	N12 (3×4)		Receptinis	EU/1/22/1685/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-22	Registruotas