IMCIVREE

Medicinal product

(Invented) name

IMCIVREE

Active substance (s)

Setmelanotidas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A08AA12, setmelanotide

Marketing authorisation holder

Rhythm Pharmaceuticals Netherlands B.V., Nyderlandai

Date of authorisation

2021-07-16

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	1 ml
Setmelanotidas	10 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
106871	92974	1092974	flakonas	1 ml N1		Receptinis	EU/1/21/1564/001	Netiekiama	-	-	No	-	-
109689	95795	1095795	flakonas	1 ml N10		Receptinis	EU/1/21/1564/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-16	Registruotas