Tramadol Krka

Medicinal product

(Invented) name

Tramadol Krka

Active substance (s)

Tramadolio hidrochloridas

Strength

100 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

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_1, 3_4 Pakuotės lapelis 200610.docx

1055_1, 3_4 Tramadol KRKA caps_ger lasai RPP 200610, rastas 3R_11209 PZ.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Tramadolio hidrochloridas	100 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
7355	12322	1012322	buteliukas	10 ml, su lašintuvu, N1		Receptinis	LT/1/94/1055/003	Netiekiama	-	-	No	-	-
8495	13208	1013208	buteliukas	96 ml, su dozavimo pompa N1		Receptinis	LT/1/94/1055/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-30	Išregistruotas
2008-03-06	Perregistruotas
1994-12-20	Registruotas