Palexia

Medicinal product

(Invented) name

Palexia

Active substance (s)

Tapentadolio hidrochloridas

Strength

4 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AX06, Tapentadol

Marketing authorisation holder

Grünenthal GmbH, Vokietija

Date of authorisation

2013-02-19

Date of renewal

2015-09-21

Documents

2341_67 Pakuotės lapelis 190829.docx

2341_67 Palexia 4mg_ml geriam tirp RPP 190829.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

8(3)

Procedure number

DE/H/2020/010/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml geriamojo tirpalo yra	1 ml
Tapentadolio hidrochloridas	4 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
47232	61048	1061048	buteliukas	100 ml ir geriamasis švirkštas bei adapteris N1		Receptinis	LT/1/10/2341/067	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-27	Išregistruotas
2015-09-21	Perregistruotas
2013-02-19	Registruotas