Fintepla

Medicinal product

(Invented) name

Fintepla

Active substance (s)

Fenfluraminas

Strength

2,2 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A08AA02, Fenfluramine

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2020-12-18

Date of renewal

Documents

Fintepla mokomoji medziaga pacientams_globejams.pdf

Fintepla mokomoji medziaga sveikatos prieziuros specialistams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral solution	1 ml
Fenfluraminas	2,2 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
105588	91688	1091688	buteliukas	60 ml, adapteris, 2×3 ml ir 2×6 ml geriamieji švirkštai, N1		Receptinis	EU/1/20/1491/001	Netiekiama	-	-	No	-	-
105589	91689	1091689	buteliukas	120 ml, adapteris, 2×3 ml ir 2×6 ml geriamieji švirkštai, N1		Receptinis	EU/1/20/1491/002	Netiekiama	-	-	No	-	-
105590	91690	1091690	buteliukas	250 ml, adapteris, 2×3 ml ir 2×6 ml geriamieji švirkštai, N1		Receptinis	EU/1/20/1491/003	Netiekiama	-	-	No	-	-
105591	91691	1091691	buteliukas	360 ml, adapteris, 2×3 ml ir 2×6 ml geriamieji švirkštai, N1		Receptinis	EU/1/20/1491/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-18	Registruotas