Fortacin

Medicinal product

(Invented) name

Fortacin

Active substance (s)

Lidokainas/Prilokainas

Strength

150 mg/50 mg/ml

Pharmaceutical form

odos purškalas (tirpalas)

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB20, Combinations

Marketing authorisation holder

Recordati Ireland Limited, Airija

Date of authorisation

2013-11-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Cutaneous spray, solution	1 ml
Lidokainas	150 mg
Prilokainas	50 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
57991	72114	1072114	purškalo talpyklė	6,5 ml (20 dozių) N1		Nereceptinis	EU/1/13/881/001	Netiekiama	-	-	No	-	-
97839	83934	1083934	purškalo talpyklė	5 ml (12 dozių) N1		Nereceptinis	EU/1/13/881/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-15	Registruotas