Ameluz

Medicinal product

(Invented) name

Ameluz

Active substance (s)

5-aminolevulino rūgštis

Strength

78 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XD04, Aminolevulinic acid

Marketing authorisation holder

Biofrontera Bioscience GmbH, Vokietija

Date of authorisation

2011-12-14

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

Gel	1 g
5-aminolevulino rūgštis	78 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
50514	64400	1064400	tūbelė	2 g N1		Receptinis	EU/1/11/740/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-12-14	Registruotas