CALUMID

Medicinal product

(Invented) name

CALUMID

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2008-07-03

Date of renewal

2013-12-31

Documents

1202_1 CALUMID 50mg tab RPP 160203.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

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
20853	5609	1005609	lizdinė plokštelė	N30		Receptinis	LT/1/08/1202/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-05	Išregistruotas
2013-12-31	Perregistruotas
2008-07-03	Registruotas