Enzalutamide Accord

Medicinal product

(Invented) name

Enzalutamide Accord

Active substance (s)

Enzalutamidas

Strength

40 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02BB04, Enzalutamide

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2024-06-17

Date of renewal

Documents

5467 Enzalutamide Accord II PL 2025 06 14.docx

5467 Pakuotės lapelis 2025 06 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/1238/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Enzalutamidas	40 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
113912	100029	1100029	lizdinė plokštelė	N28		Receptinis	LT/1/24/5467/001	Netiekiama	-	-	No	-	-
113913	100030	1100030	lizdinė plokštelė	N112 (4×28)		Receptinis	LT/1/24/5467/002	Netiekiama	-	2028-06-24	No	-	-

Stadijos

Data	Stadija
2024-06-17	Registruotas