Gemcitabine Hospira

Medicinal product

(Invented) name

Gemcitabine Hospira

Active substance (s)

Gemcitabinas

Strength

38 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)

L01BC05, Gemcitabine

Marketing authorisation holder

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2011-09-28

Date of renewal

Documents

0822_7_9 Gemcitabine Hospira konc RPP 160314.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/1862/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Gemcitabinas	38 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
33848	36209	1036209	buteliukas	5,3 ml N1		Receptinis	LT/1/07/0822/007	Netiekiama	-	-	No	-	-
33849	36210	1036210	buteliukas	26,3 ml N1		Receptinis	LT/1/07/0822/008	Netiekiama	-	-	No	-	-
33850	36211	1036211	buteliukas	52,6 ml N1		Receptinis	LT/1/07/0822/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-10-05	Išregistruotas
2011-09-28	Registruotas