Fragmin

Medicinal product

(Invented) name

Fragmin

Active substance (s)

Dalteparino natrio druska

Strength

10000 anti-Xa TV/0,4 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AB04, Dalteparin

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2002-06-05

Date of renewal

2009-04-01

Documents

1505 Pakuotės lapelis 10000_0,4ml 2022 07 25.docx

1505 Fragmin 10000_0,4ml PCS PL 2022 07 25.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Švirkšte (0,4 ml tirpalo) yra	0.4 ml
Dalteparino natrio druska	10000 anti-Xa TV

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
5163	10457	1010457	užpildytas švirkštas	0,4 ml N5		Receptinis	LT/1/99/1505/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-30	Išregistruotas
2009-04-01	Perregistruotas
2002-06-05	Registruotas