PecFent

Medicinal product

(Invented) name

PecFent

Active substance (s)

Fentanilis

Strength

100 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	100 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
42560	56327	1056327	buteliukas	1,55 ml N1		Receptinis	EU/1/10/644/001	Netiekiama	-	-	No	-	-
42561	56328	1056328	buteliukas	1,55 ml N4		Receptinis	EU/1/10/644/002	Netiekiama	-	-	No	-	-
50358	64242	1064242	buteliukas	1,55 ml N12		Receptinis	EU/1/10/644/005	Netiekiama	-	-	No	-	-
66693	81230	1081230	buteliukas	0,95 ml N1		Receptinis	EU/1/10/644/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-08-31	Registruotas