Tadalafil Accord

Medicinal product

(Invented) name

Tadalafil Accord

Active substance (s)

Tadalafilis

Strength

10 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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-09-26

Date of renewal

2022-04-22

Documents

3972 Tadalafil Accord II PL 2024 12 05.docx

3972 Pakuotės lapelis 10mg 2024 12 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1037/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Tadalafilis	10 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
61519	75859	1075859	lizdinė plokštelė	N4		Receptinis	LT/1/16/3972/006	Netiekiama	-	-	No	-	-
98482	84585	1084585	lizdinė plokštelė	N14		Receptinis	LT/1/16/3972/013	Netiekiama	-	-	No	-	-
98483	84586	1084586	lizdinė plokštelė	N28		Receptinis	LT/1/16/3972/014	Netiekiama	-	-	No	-	-
98484	84587	1084587	lizdinė plokštelė	N30		Receptinis	LT/1/16/3972/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-22	Perregistruotas
2016-09-26	Registruotas