Darunavir Krka

Medicinal product

(Invented) name

Darunavir Krka

Active substance (s)

Darunaviras

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)

J05AE10, Darunavir

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-01-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Darunaviras	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
98853	84957	1084957	buteliukas	N30		Receptinis	EU/1/17/1249/001	Netiekiama	-	-	No	-	-
98854	84958	1084958	buteliukas	N60 (2x30)		Receptinis	EU/1/17/1249/002	Netiekiama	-	-	No	-	-
98855	84959	1084959	buteliukas	N90 (3x30)		Receptinis	EU/1/17/1249/003	Netiekiama	-	-	No	-	-
98856	84960	1084960	buteliukas	N180 (6x30)		Receptinis	EU/1/17/1249/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-26	Registruotas