Arixtra

Medicinal product

(Invented) name

Arixtra

Active substance (s)

Fondaparinukso natrio druska

Strength

10 mg/0,8 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AX05, Fondaparinux

Marketing authorisation holder

Viatris Healthcare Limited, Airija

Date of authorisation

2004-11-12

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	0.8 ml
Fondaparinukso natrio druska	10 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
24930	27561	1027561	užpildytas švirkštas	0,8 ml N2 (su automatine saugos sistema)		Receptinis	EU/1/02/206/015	Netiekiama	-	-	No	-	-
24931	27562	1027562	užpildytas švirkštas	0,8 ml N7 (su automatine saugos sistema)		Receptinis	EU/1/02/206/016	Netiekiama	-	-	No	-	-
24932	27563	1027563	užpildytas švirkštas	0,8 ml N10 (su automatine saugos sistema)		Receptinis	EU/1/02/206/017	Netiekiama	-	-	No	-	-
24933	27564	1027564	užpildytas švirkštas	0,8 ml N20 (su automatine saugos sistema)		Receptinis	EU/1/02/206/020	Netiekiama	-	-	No	-	-
31656	34074	1034074	užpildytas švirkštas	0,8 ml N2 (su rankine saugos sistema)		Receptinis	EU/1/02/206/031	Netiekiama	-	-	No	-	-
31657	34075	1034075	užpildytas švirkštas	0,8 ml N10 (su rankine saugos sistema)		Receptinis	EU/1/02/206/032	Netiekiama	-	-	No	-	-
31658	34076	1034076	užpildytas švirkštas	0,8 ml N20 (su rankine saugos sistema)		Receptinis	EU/1/02/206/035	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-11-12	Registruotas