Actikerall

Medicinal product

(Invented) name

Actikerall

Active substance (s)

Fluorouracilas/Salicilo rūgštis

Strength

5 mg/100 mg/g

Pharmaceutical form

odos tirpalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC52, Fluorouracil, combinations

Marketing authorisation holder

Almirall Hermal GmbH, Vokietija

Date of authorisation

2013-10-09

Date of renewal

Documents

3377_1 Actikerall PCS PL 161031.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DE/H/3523/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g (1,05 ml) odos tirpalo yra	1.05 ml
Fluorouracilas	5 mg
Salicilo rūgštis	100 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
50416	64301	1064301	buteliukas	25 ml N1		Receptinis	LT/1/13/3377/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-31	Išregistruotas
2013-10-09	Registruotas