Testosterone undecanoate Orifarm

Medicinal product

(Invented) name

Testosterone undecanoate Orifarm

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

Orifarm Healthcare A/S, Danija

Date of authorisation

2024-05-21

Date of renewal

Documents

5446_pakuotes lapelis_2024-05-21.docx

5446_Testosterone_undec_Orifarm.docx

Testosterone undecanoate Orifarm mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5749/001/DC

Marketing authorisation procedure

Decentralizuota 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
113696	99815	1099815	ampulė	4 ml N1		Receptinis	LT/1/24/5446/001	Netiekiama	-	-	No	-	-
113697	99816	1099816	flakonas	4 ml N1		Receptinis	LT/1/24/5446/002	Netiekiama	2025-08-06	2025-12-11	Yes	2025-08-14	2025-12-15	Download

Stadijos

Data	Stadija
2024-05-21	Registruotas