CLEXANE [Clexane]

Medicinal product

(Invented) name

CLEXANE [Clexane]

Active substance (s)

Enoksaparino natrio druska

Strength

10000 TV (100 mg)/1 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, hemodializei, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AB05, Enoxaparin

Marketing authorisation holder

SANOFI-AVENTIS LIETUVA, UAB, Lietuva

Date of authorisation

1998-07-01

Date of renewal

2010-11-10

Documents

1560_5_14 CLEXANE_inj RPP 170607.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/0751/

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Švirkšte (1 ml tirpalo) yra	1 ml
Enoksaparino natrio druska	10000 TV (100 mg)/1 ml

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
10020	14620	1014620	užpildytas švirkštas	1,0 ml N2		Receptinis	LT/1/98/1560/013	Netiekiama	-	-	No	-	-
10021	14621	1014621	užpildytas švirkštas	1,0 ml N10		Receptinis	LT/1/98/1560/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-10	Išregistruotas
2010-11-10	Perregistruotas
1998-07-01	Registruotas