Tramadol Krka

Medicinal product

(Invented) name

Tramadol Krka

Active substance (s)

Tramadolio hidrochloridas

Strength

50 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)

N02AX02, Tramadol

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

1994-12-20

Date of renewal

2008-03-06

Documents

1055 Tramadol Krka kaps PCS PL 2024 09 30.docx

1055 Pakuotės lapelis kaps 2024 09 30.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Tramadolio hidrochloridas	50 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
7356	1886	1001886	lizdinė plokštelė	N20		Receptinis	LT/1/94/1055/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-03-06	Perregistruotas
1994-12-20	Registruotas