Rudotel

Medicinal product

(Invented) name

Rudotel

Active substance (s)

Medazepamas

Strength

10 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05BA03, Medazepam

Marketing authorisation holder

Teva Pharma B.V., Nyderlandai

Date of authorisation

1995-04-05

Date of renewal

2008-03-06

Documents

1052 Rudotel PCS PL 2023 03 02.docx

1052 Pakuotės lapelis 2023 03 02.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Medazepamas	10 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
1068	6918	1006918	buteliukas	N20		Receptinis	LT/1/95/1052/001	Netiekiama	-	-	No	-	-
1069	6919	1006919	buteliukas	N50		Receptinis	LT/1/95/1052/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-03-06	Perregistruotas
1995-04-05	Registruotas