Isentress

Medicinal product

(Invented) name

Isentress

Active substance (s)

Raltegraviras

Strength

400 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

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2007-12-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablets	1 vnt.
Raltegraviras	400 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
29295	31795	1031795	buteliukas	N60		Receptinis	EU/1/07/436/001	Tiekiama	-	-	No	-	-
29296	31796	1031796	buteliukas	N180 (3x60)		Receptinis	EU/1/07/436/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-20	Registruotas