Slenyto

Medicinal product

(Invented) name

Slenyto

Active substance (s)

Melatoninas

Strength

1 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Purpose for use

vaikams ir paaugliams

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05CH01, Melatonin

Marketing authorisation holder

RAD Neurim Pharmaceuticals EEC SARL, Prancūzija

Date of authorisation

2018-09-20

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

Prolonged-release tablet	1 vnt.
Melatoninas	1 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
100294	86403	1086403	lizdinė plokštelė	N60		Receptinis	EU/1/18/1318/001	Netiekiama	2024-12-15	-	Yes	2025-07-02	2026-06-30
101265	87372	1087372	lizdinė plokštelė	N30		Receptinis	EU/1/18/1318/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-20	Registruotas