Pamidronate Disodium Hospira

Medicinal product

(Invented) name

Pamidronate Disodium Hospira

Active substance (s)

Dinatrio pamidronatas

Strength

3 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BA03, Pamidronic acid

Marketing authorisation holder

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2005-06-09

Date of renewal

2008-02-22

Documents

0230_1_8 Pamidronate Disodium Hospira PZ 171215.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/0420/

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Dinatrio pamidronatas	3 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
14319	18572	1018572	buteliukas	buteliukas (5 ml), N5		Receptinis	LT/1/05/0230/001	Netiekiama	-	-	No	-	-
14320	18573	1018573	buteliukas	buteliukas (5 ml), N20		Receptinis	LT/1/05/0230/002	Netiekiama	-	-	No	-	-
16546	20572	1020572	buteliukas	buteliukas (10 ml), N1		Receptinis	LT/1/05/0230/003	Netiekiama	-	-	No	-	-
16547	20573	1020573	buteliukas	buteliukas (10 ml), N4		Receptinis	LT/1/05/0230/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-05	Išregistruotas
2008-02-22	Perregistruotas
2005-06-09	Registruotas