PecFent

Medicinal product

(Invented) name

PecFent

Active substance (s)

Fentanilis

Strength

400 µg/išpurškime

Pharmaceutical form

nosies purškalas (tirpalas)

Route (s) of administration

vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

Grünenthal GmbH, Vokietija

Date of authorisation

2010-08-31

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Nasal spray, solution	1 išpurškime
Fentanilis	400 µg

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
42558	56325	1056325	buteliukas	1,55 ml N1		Receptinis	EU/1/10/644/003	Netiekiama	-	-	No	-	-
42559	56326	1056326	buteliukas	1,55 ml N4		Receptinis	EU/1/10/644/004	Netiekiama	-	-	No	-	-
50359	64243	1064243	buteliukas	1,55 ml N12		Receptinis	EU/1/10/644/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-08-31	Registruotas