Tadalafil Zentiva

Medicinal product

(Invented) name

Tadalafil Zentiva

Active substance (s)

Tadalafilis

Strength

5 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

Zentiva k.s., Čekija

Date of authorisation

2023-12-08

Date of renewal

Documents

5290 Pakuotės lapelis 5mg 2024 04 26.docx

5290_5291 Tadalafil Zentiva RPP 2024 04 26.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1646/001/E002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Tadalafilis	5 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
112269	98384	1098384	lizdinė plokštelė	N14		Receptinis	LT/1/23/5290/001	Netiekiama	-	-	No	-	-
112270	98385	1098385	lizdinė plokštelė	N28		Receptinis	LT/1/23/5290/002	Tiekiama	-	-	No	-	-
113519	99638	1099638	lizdinė plokštelė	N84		Receptinis	LT/1/23/5290/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-08	Registruotas