Fleree

Medicinal product

(Invented) name

Fleree

Active substance (s)

Levonorgestrelis

Strength

13,5 mg

Pharmaceutical form

vartojimo į gimdos ertmę sistema

Route (s) of administration

vartoti į gimdos ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G02BA03, Plastic IUD with progestogen

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2013-02-19

Date of renewal

2019-02-08

Documents

3219 Pakuotės lapelis 2024 05 03.docx

3219 Fleree PCS 2025 04 17.docx

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1186/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vartojimo į gimdos ertmę sistemoje yra	1 vnt.
Levonorgestrelis	13,5 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
50157	64033	1064033	lizdinė plokštelė	N1		Receptinis	LT/1/13/3219/001	Tiekiama	-	-	No	-	-	Download
55254	69301	1069301	lizdinė plokštelė	N5		Receptinis	LT/1/13/3219/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-08	Perregistruotas
2013-02-19	Registruotas