Arixtra

Medicinal product

(Invented) name

Arixtra

Active substance (s)

Fondaparinukso natrio druska

Strength

1,5 mg/0,3 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

2003-10-24

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	0.3 ml
Fondaparinukso natrio druska	1,5 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
24918	27549	1027549	užpildytas švirkštas	0,3 ml N2 (su automatine saugos sistema)		Receptinis	EU/1/02/206/005	Netiekiama	-	-	No	-	-
24919	27550	1027550	užpildytas švirkštas	0,3 ml N7 (su automatine saugos sistema)		Receptinis	EU/1/02/206/006	Netiekiama	-	-	No	-	-
24920	27551	1027551	užpildytas švirkštas	0,3 ml N10 (su automatine saugos sistema)		Receptinis	EU/1/02/206/007	Netiekiama	-	-	No	-	-
24921	27552	1027552	užpildytas švirkštas	0,3 ml N20 (su automatine saugos sistema)		Receptinis	EU/1/02/206/008	Netiekiama	-	-	No	-	-
31643	34061	1034061	užpildytas švirkštas	0,3 ml N2 (su rankine saugos sistema)		Receptinis	EU/1/02/206/024	Netiekiama	-	-	No	-	-
31644	34062	1034062	užpildytas švirkštas	0,3 ml N10 (su rankine saugos sistema)		Receptinis	EU/1/02/206/025	Netiekiama	-	-	No	-	-
31645	34063	1034063	užpildytas švirkštas	0,3 ml N20 (su rankine saugos sistema)		Receptinis	EU/1/02/206/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-10-24	Registruotas