Oxaliplatin-Teva

Medicinal product

(Invented) name

Oxaliplatin-Teva

Active substance (s)

Oksaliplatina

Strength

5 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)

L01XA03, Oxaliplatin

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2007-11-30

Date of renewal

2012-09-27

Documents

0921_4_7 Oxaliplatin_Teva konc inf PCS PL 191016.docx

0921_4_7 Pakuotės lapelis 191016.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0820/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Oksaliplatina	5 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
19494	22787	1022787	buteliukas	20 mg N1		Receptinis	LT/1/07/0921/004	Netiekiama	-	-	No	-	-
19495	22788	1022788	buteliukas	50 mg N1		Receptinis	LT/1/07/0921/005	Netiekiama	-	-	No	-	-	Download
19496	22789	1022789	buteliukas	100 mg N1		Receptinis	LT/1/07/0921/006	Netiekiama	-	-	No	-	-
34551	36893	1036893	buteliukas	200 mg N1		Receptinis	LT/1/07/0921/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2012-09-27	Perregistruotas
2007-11-30	Registruotas