Arixtra

Medicinal product

(Invented) name

Arixtra

Active substance (s)

Fondaparinukso natrio druska

Strength

7,5 mg/0,6 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	0.6 ml
Fondaparinukso natrio druska	7,5 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
24926	27557	1027557	užpildytas švirkštas	0,6 ml N2 (su automatine saugos sistema)		Receptinis	EU/1/02/206/012	Netiekiama	-	-	No	-	-
24927	27558	1027558	užpildytas švirkštas	0,6 ml N7 (su automatine saugos sistema)		Receptinis	EU/1/02/206/013	Netiekiama	-	-	No	-	-
24928	27559	1027559	užpildytas švirkštas	0,6 ml N10 (su automatine saugos sistema)		Receptinis	EU/1/02/206/014	Netiekiama	-	-	No	-	-
24929	27560	1027560	užpildytas švirkštas	0,6 ml N20 (su automatine saugos sistema)		Receptinis	EU/1/02/206/019	Netiekiama	-	-	No	-	-
31653	34071	1034071	užpildytas švirkštas	0,6 ml N2 (su rankine saugos sistema)		Receptinis	EU/1/02/206/029	Netiekiama	-	-	No	-	-
31654	34072	1034072	užpildytas švirkštas	0,6 ml N10 (su rankine saugos sistema)		Receptinis	EU/1/02/206/030	Netiekiama	-	-	No	-	-
31655	34073	1034073	užpildytas švirkštas	0,6 ml N20 (su rankine saugos sistema)		Receptinis	EU/1/02/206/034	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-11-12	Registruotas