Tadalafil Mylan

Medicinal product

(Invented) name

Tadalafil Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2014-11-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
60818	75108	1075108	lizdinė plokštelė	N4		Receptinis	EU/1/14/961/001	Netiekiama	-	-	No	-	-
60819	75109	1075109	lizdinė plokštelė	N12		Receptinis	EU/1/14/961/010	Netiekiama	-	-	No	-	-
60820	75110	1075110	lizdinė plokštelė	N24		Receptinis	EU/1/14/961/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-21	Registruotas