Medikinet XL

Medicinal product

(Invented) name

Medikinet XL

Active substance (s)

Metilfenidato hidrochloridas

Strength

5 mg

Pharmaceutical form

modifikuoto atpalaidavimo kietosios kapsulės

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

Medice Arzneimittel Pütter GmbH & Co KG, Vokietija

Date of authorisation

2010-12-28

Date of renewal

2014-01-24

Documents

2274 Medikinet XL kaps PCS PL 2023 11 20.docx

2274 Pakuotės lapelis 2023 11 20.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(3)

Procedure number

DE/H/2223/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Metilfenidato hidrochloridas	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
33364	35731	1035731	lizdinė plokštelė	N28		Receptinis	LT/1/10/2274/001	Netiekiama	-	-	No	-	-
44432	58225	1058225	lizdinė plokštelė	N30		Receptinis	LT/1/10/2274/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-24	Perregistruotas
2010-12-28	Registruotas