Lenzetto

Medicinal product

(Invented) name

Lenzetto

Active substance (s)

Estradiolis

Strength

1,53 mg/išpurškime

Pharmaceutical form

transderminis purškalas (tirpalas)

Route (s) of administration

vartoti per odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03CA03, Estradiol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2015-09-21

Date of renewal

2021-05-24

Documents

3791 Pakuotės lapelis 2024 01 10.docx

3791 Lenzetto PCS PL 2024 01 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

HU/H/0361/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename išpurškime yra	1 išpurškime
Estradiolis	1,53 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
57901	72022	1072022	purškalo talpyklė	56 išpurškimai N1		Receptinis	LT/1/15/3791/001	Tiekiama	-	-	No	-	-
65551	80059	1080059	purškalo talpyklė	56 išpurškimai N3		Receptinis	LT/1/15/3791/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-24	Perregistruotas
2015-09-21	Registruotas