Isentress

Medicinal product

(Invented) name

Isentress

Active substance (s)

Raltegraviras

Strength

100 mg

Pharmaceutical form

granulės geriamajai suspensijai

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

Granules for oral suspension	1 vnt.
Raltegraviras	100 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
60542	74821	1074821	paketėlis	N60 (2x1 ml, 3 ml, 10 ml švirkštai ir maišymo taurelė)		Receptinis	EU/1/07/436/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-20	Registruotas