Effentora

Medicinal product

(Invented) name

Effentora

Active substance (s)

Fentanilis

Strength

800 µg

Pharmaceutical form

žandinės tabletės

Route (s) of administration

vartoti ant burnos gleivinės

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2008-04-04

Date of renewal

Documents

Effentora mokomoji medziaga vaistininkams.pdf

Effentora mokomoji medziaga pacientams.pdf

Effentora mokomoji medziaga gydytojams.pdf

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Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Buccal tablet	1 vnt.
Fentanilis	800 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
44243	58035	1058035	lizdinė plokštelė	N4		Receptinis	EU/1/08/441/009	Netiekiama	-	-	No	-	-
44244	58036	1058036	lizdinė plokštelė	N28		Receptinis	EU/1/08/441/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-04-04	Registruotas