Osmetil

Medicinal product

(Invented) name

Osmetil

Active substance (s)

Metilfenidato hidrochloridas

Strength

54 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06BA04, Methylphenidate

Marketing authorisation holder

UAB Exeltis Baltics, Lietuva

Date of authorisation

2025-12-04

Date of renewal

Documents

5919_5923 Pakuotės lapelis 2025 12 04.docx

5919_5923 Osmetil PCS PL 2025 12 04.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

SE/H/1912/004/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Metilfenidato hidrochloridas	54 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
119358	105463	1105463	buteliukas	N30		Receptinis	LT/1/25/5923/001	Netiekiama	-	-	No	-	-
119359	105464	1105464	buteliukas	N60 (2×30)		Receptinis	LT/1/25/5923/002	Netiekiama	-	-	No	-	-
119360	105465	1105465	buteliukas	N90 (3×30)		Receptinis	LT/1/25/5923/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-04	Registruotas