Enzalutamide Norameda

Medicinal product

(Invented) name

Enzalutamide Norameda

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

UAB Norameda, Lietuva

Date of authorisation

2023-06-21

Date of renewal

Documents

5192 Enzalutamide Norameda PCS PL 2025 02 10.docx

5192 Pakuotės lapelis 2025 02 10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1129/001/E/001

Marketing authorisation procedure

Kartotinė 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
111161	97272	1097272	lizdinė plokštelė	N28		Receptinis	LT/1/23/5192/001	Netiekiama	-	-	No	-	-
111162	97273	1097273	lizdinė plokštelė	N112		Receptinis	LT/1/23/5192/002	Netiekiama	-	-	No	-	-
111163	97274	1097274	lizdinė plokštelė	N120		Receptinis	LT/1/23/5192/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-21	Registruotas