Qsiva

Medicinal product

(Invented) name

Qsiva

Active substance (s)

Fenterminas/Topiramatas

Strength

3,75 mg/23 mg

Pharmaceutical form

modifikuoto atpalaidavimo kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

A08AA51, phentermine and topiramate

Marketing authorisation holder

Vivus B.V., Nyderlandai

Date of authorisation

2024-09-09

Date of renewal

Documents

5562_5565 Qsiva PCS PL 2025 06 05.docx

5562_5565 Pakuotės lapelis 2025 06 05.docx

Qsiva mokomoji medziaga pacientui.pdf

Qsiva mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1963/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Fenterminas	3,75 mg
Topiramatas	23 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
114907	101012	1101012	buteliukas	N14		Receptinis	LT/1/24/5562/001	Netiekiama	-	-	No	-	-
114908	101013	1101013	buteliukas	N30		Receptinis	LT/1/24/5562/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-09	Registruotas