Gliolan

Medicinal product

(Invented) name

Gliolan

Active substance (s)

5-aminolevulino rūgšties hidrochloridas

Strength

30 mg/ml

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XD04, Aminolevulinic acid

Marketing authorisation holder

photonamic GmbH & Co. KG, Vokietija

Date of authorisation

2007-09-07

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

One ml of reconstituted solution contains:	1 ml
5-aminolevulino rūgšties hidrochloridas	30 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
26071	28660	1028660	flakonas	N1		Receptinis	EU/1/07/413/001	Tiekiama	-	-	No	-	-
26072	28661	1028661	flakonas	N2		Receptinis	EU/1/07/413/002	Netiekiama	-	-	No	-	-
26073	28662	1028662	flakonas	N10		Receptinis	EU/1/07/413/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-07	Registruotas