Winlevi

Medicinal product

(Invented) name

Winlevi

Active substance (s)

Klaskoteronas

Strength

10 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10AX06, clascoterone

Marketing authorisation holder

Cassiopea S.p.A., Italija

Date of authorisation

2025-10-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 g kremo yra:	1 g
Klaskoteronas	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
118973	105079	1105079	tūbelė	10 g N1		Receptinis	EU/1/25/1927/001	Netiekiama	-	-	No	-	-
118974	105080	1105080	tūbelė	30 g N1		Receptinis	EU/1/25/1927/002	Netiekiama	-	-	No	-	-
118975	105081	1105081	tūbelė	60 g N1		Receptinis	EU/1/25/1927/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-17	Registruotas