Raltegravir Zentiva

Medicinal product

(Invented) name

Raltegravir Zentiva

Active substance (s)

Raltegraviras

Strength

600 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AJ01, Raltegravir

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2025-05-05

Date of renewal

Documents

5777 Raltegravir Zentiva RPP 2025 06 24.docx

5777 Pakuotės lapelis 2025 06 24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0588/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Raltegraviras	600 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
117399	103501	1103501	buteliukas	N60		Receptinis	LT/1/25/5777/001	Netiekiama	-	-	No	-	-
117400	103505	1103505	buteliukas	N180 (3×60)		Receptinis	LT/1/25/5777/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-05	Registruotas