Tranxene

Medicinal product

(Invented) name

Tranxene

Active substance (s)

Dikalio klorazepatas

Strength

10 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05BA05, Potassium clorazepate

Marketing authorisation holder

neuraxpharm Arzneimittel GmbH, Vokietija

Date of authorisation

1996-02-15

Date of renewal

2012-07-25

Documents

3013 Tranxene RPP 2023 10 31.docx

3013 Pakuotės lapelis 2023 10 31.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Dikalio klorazepatas	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
1703	1901	1001901	lizdinė plokštelė	N30		Receptinis	LT/1/96/3013/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-07-25	Perregistruotas
1996-02-15	Registruotas