Truvada

Medicinal product

(Invented) name

Truvada

Active substance (s)

Emtricitabinas/Tenofoviro dizoproksilis

Strength

200 mg/245 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)

J05AR03, Tenofovir disoproxil and emtricitabine

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2005-02-21

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 tablet	1 vnt.
Emtricitabinas	200 mg
Tenofoviro dizoproksilis	245 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
28947	31459	1031459	buteliukas	N30		Receptinis	EU/1/04/305/001	Netiekiama	-	-	No	-	-
38420	52078	1052078	buteliukas	N90 (3x30)		Receptinis	EU/1/04/305/002	Netiekiama	-	-	No	-	-
103515	89617	1089617	buteliukas	N60 (2x30)		Receptinis	EU/1/04/305/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-02-21	Registruotas