IONSYS

Medicinal product

(Invented) name

IONSYS

Active substance (s)

Fentanilis

Strength

40 µg/dozėje

Pharmaceutical form

transderminė sistema

Route (s) of administration

vartoti per odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

Incline Therapeutics Europe Ltd., Jungtinė Karalystė

Date of authorisation

2015-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Transdermal system	1 vnt.
Fentanilis	40 µg/dozėje

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
64387	78870	1078870	paketėlis	N6		Receptinis	EU/1/15/1050/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2015-11-19	Registruotas