Nebido

Medicinal product

(Invented) name

Nebido

Active substance (s)

Testosterono undekanoatas

Strength

1000 mg/4 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03BA03, Testosterone

Marketing authorisation holder

Grünenthal GmbH, Vokietija

Date of authorisation

2005-05-18

Date of renewal

2009-11-04

Documents

0222 Nebido PCS II PL 2024 11 11.docx

Nebido mokomoji medziaga sveikatos prieziuros specialistams.pdf

0222 Pakuotės lapelis 2024 11 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FI/H/0313/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Ampulėje/flakone (4 ml tirpalo) yra:	4 ml
Testosterono undekanoatas	1000 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
13870	4441	1004441	ampulė	4 ml N1		Receptinis	LT/1/05/0222/001	Netiekiama	-	-	No	-	-
54512	68509	1068509	flakonas	4 ml N1		Receptinis	LT/1/05/0222/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-11-04	Perregistruotas
2005-05-18	Registruotas