Tadalafil Mylan

Medicinal product

(Invented) name

Tadalafil Mylan

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

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	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
60821	75111	1075111	lizdinė plokštelė	N2		Receptinis	EU/1/14/961/002	Netiekiama	-	-	No	-	-
60822	75112	1075112	lizdinė plokštelė	N4		Receptinis	EU/1/14/961/003	Netiekiama	-	-	No	-	-
60823	75113	1075113	lizdinė plokštelė	N8		Receptinis	EU/1/14/961/004	Netiekiama	-	-	No	-	-
60824	75114	1075114	lizdinė plokštelė	N12		Receptinis	EU/1/14/961/005	Netiekiama	-	-	No	-	-
60825	75115	1075115	lizdinė plokštelė	N24		Receptinis	EU/1/14/961/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-21	Registruotas