Bicalutamide Actiofarma

Medicinal product

(Invented) name

Bicalutamide Actiofarma

Active substance (s)

Bikalutamidas

Strength

50 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)

L02BB03, Bicalutamide

Marketing authorisation holder

UAB Actiofarma, Lietuva

Date of authorisation

2021-01-11

Date of renewal

Documents

1464-001-003_Bicalutamide Actiofarma_50mg_pl_deng_tab_PZPL_2021-01-11.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

tabletėje yra	1 vnt.
Bikalutamidas	50 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
105633	91733	1091733	lizdinė plokštelė	N30		Receptinis	LT/L/21/1464/001	Netiekiama	-	-	No	-	-	Download
105634	91734	1091734	lizdinė plokštelė	N60		Receptinis	LT/L/21/1464/002	Netiekiama	-	-	No	-	-	Download
105635	91735	1091735	lizdinė plokštelė	N90		Receptinis	LT/L/21/1464/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
	Išregistruotas
2021-01-11	Registruotas