Tadalafil AOP

Medicinal product

(Invented) name

Tadalafil AOP

Active substance (s)

Tadalafilis

Strength

20 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)

G04BE08, Tadalafil

Marketing authorisation holder

AOP Orphan Pharmaceuticals GmbH, Austrija

Date of authorisation

2019-04-30

Date of renewal

2024-05-27

Documents

4384_Tadalafil AOP_perr2024-05-27.docx

4384_pakuotes lapelis_2024-05-27.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4322/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Tadalafilis	20 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
101557	87660	1087660	lizdinė plokštelė	N28		Receptinis	LT/1/19/4384/001	Netiekiama	-	-	No	-	-
101558	87661	1087661	lizdinė plokštelė	N56		Receptinis	LT/1/19/4384/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-08-29	Išregistruotas
2024-05-27	Perregistruotas
2019-04-30	Registruotas