Granisetron Teva

Medicinal product

(Invented) name

Granisetron Teva

Active substance (s)

Granisetronas

Strength

3 mg/3 ml

Pharmaceutical form

koncentratas injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA02, Granisetron

Marketing authorisation holder

Teva Pharma B.V., Nyderlandai

Date of authorisation

2008-06-02

Date of renewal

2013-11-22

Documents

1155_7_12 Granisetron Teva konc RPP 170531.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

UK/H/1091/002/R/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

3 ml koncentrato yra	3 ml
Granisetronas	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
22070	24898	1024898	ampulė	3 ml N1		Receptinis	LT/1/08/1155/007	Netiekiama	-	-	No	-	-
22312	5037	1005037	ampulė	3 ml N5		Receptinis	LT/1/08/1155/008	Netiekiama	-	-	No	-	-	Download
30201	32668	1032668	ampulė	3 ml N10		Receptinis	LT/1/08/1155/009	Netiekiama	-	-	No	-	-
30202	32669	1032669	flakonas	3 ml N1		Receptinis	LT/1/08/1155/010	Netiekiama	-	-	No	-	-
30203	32670	1032670	flakonas	3 ml N5		Receptinis	LT/1/08/1155/011	Netiekiama	-	-	No	-	-
30204	32671	1032671	flakonas	3 ml N10		Receptinis	LT/1/08/1155/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-10-05	Išregistruotas
2013-11-22	Perregistruotas
2008-06-02	Registruotas