Daklinza

Medicinal product

(Invented) name

Daklinza

Active substance (s)

Daklatasviras

Strength

90 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, Jungtinė Karalystė

Date of authorisation

2014-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Daklatasviras	90 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
66326	80851	1080851	lizdinė plokštelė	N28		Receptinis	EU/1/14/939/005	Netiekiama	-	-	No	-	-
66327	80852	1080852	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/14/939/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2014-08-22	Registruotas