Daklinza

Medicinal product

(Invented) name

Daklinza

Active substance (s)

Daklatasviras

Strength

60 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)

J05AP07, Daclatasvir

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2014-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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.
Daklatasviras	60 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
59935	74205	1074205	lizdinė plokštelė	N28 (kalendorinė)		Receptinis	EU/1/14/939/003	Netiekiama	-	-	No	-	-
59936	74206	1074206	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/14/939/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-08-22	Išregistruotas
2014-08-22	Registruotas