Fragmin

Medicinal product

(Invented) name

Fragmin

Active substance (s)

Dalteparino natrio druska

Strength

10000 anti-Xa TV/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

1999-10-08

Date of renewal

2009-04-01

Documents

1505 Pakuotės lapelis 10000_1ml 2022 07 25.docx

1505 Fragmin 10000_1ml 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

1 ml tirpalo yra	1 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
276	6239	1006239	ampulė	1 ml N10		Receptinis	LT/1/99/1505/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-01-30	Išregistruotas
2009-04-01	Perregistruotas
1999-10-08	Registruotas