Kyleena

Medicinal product

(Invented) name

Kyleena

Active substance (s)

Levonorgestrelis

Strength

19,5 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

2017-01-03

Date of renewal

2021-05-24

Documents

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

4028 Kyleena PCS PL 2025 11 12.docx

4028 Pakuotės lapelis 2025 11 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1587/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vartojimo į gimdos ertmę sistemoje yra	1 vnt.
Levonorgestrelis	19,5 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
64218	78678	1078678	lizdinė plokštelė	N1×1		Receptinis	LT/1/17/4028/001	Tiekiama	-	-	No	-	-	Download
67385	81935	1081935	lizdinė plokštelė	N5×1		Receptinis	LT/1/17/4028/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-24	Perregistruotas
2017-01-03	Registruotas