Tramadol Krka

Medicinal product

(Invented) name

Tramadol Krka

Active substance (s)

Tramadolio hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti po oda

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 inj tirp PCS PL 2024 09 30.docx

1055 Pakuotės lapelis inj tirp 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

Ampulėje (1 ml tirpalo) yra	1 ml
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
7353	1887	1001887	ampulė	1 ml, N5		Receptinis	LT/1/94/1055/005	Netiekiama	-	-	No	-	-	Download

Stadijos

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