Estradiol Besins

Medicinal product

(Invented) name

Estradiol Besins

Active substance (s)

Estradiolis

Strength

0,75 mg/dozėje

Pharmaceutical form

transderminis gelis

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

Besins Healthcare Ireland Limited, Airija

Date of authorisation

2020-12-22

Date of renewal

2025-01-28

Documents

4648_pakuotes lapelis_2025-01-28.docx

4648_Estradiol Besins_perr2025-01-28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

BE/H/0278/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 gelio dozėje (1,25 g) yra:	1 g
Estradiolis	0,75 mg/dozėje

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
105484	91584	1091584	buteliukas	80 g (60 dozių) N1		Receptinis	LT/1/20/4648/001	Netiekiama	-	-	No	-	-
105485	91585	1091585	buteliukas	80 g (60 dozių) N2		Receptinis	LT/1/20/4648/002	Netiekiama	-	-	No	-	-
105486	91586	1091586	buteliukas	80 g (60 dozių) N3		Receptinis	LT/1/20/4648/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-28	Perregistruotas
2020-12-22	Registruotas