Protamine sulphate LEO Pharma

Medicinal product

(Invented) name

Protamine sulphate LEO Pharma

Active substance (s)

Protamino sulfatas

Strength

1400 TV/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB14, Protamine

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

2007-12-20

Date of renewal

2010-12-15

Documents

0953 Protamine Sulphate LEO Pharma PL 2022 11 15, VRA_20332.docx

0953 Pakuotės lapelis 2022 11 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/0562/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Protamino sulfatas	1400 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
18611	22201	1022201	ampulė	5 ml N5		Receptinis	LT/1/07/0953/001	Tiekiama	-	-	No	-	-	Download
18612	22202	1022202	ampulė	5 ml N50		Receptinis	LT/1/07/0953/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-12-15	Perregistruotas
2007-12-20	Registruotas