Scenesse

Medicinal product

(Invented) name

Scenesse

Active substance (s)

Afamelanotidas

Strength

16 mg

Pharmaceutical form

implantas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D02BB02, Afamelanotide

Marketing authorisation holder

Clinuvel Europe Limited, Airija

Date of authorisation

2014-12-22

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

Implant	1 vnt.
Afamelanotidas	16 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
60978	75287	1075287	flakonas	N1		Receptinis	EU/1/14/969/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-12-22	Registruotas