Paclitaxel SanoSwiss

Medicinal product

(Invented) name

Paclitaxel SanoSwiss

Active substance (s)

Paklitakselis

Strength

6 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)

L01CD01, Paclitaxel

Marketing authorisation holder

SanoSwiss, UAB, Lietuva

Date of authorisation

2016-09-26

Date of renewal

2018-10-08

Documents

3971_1_4 Paclitaxel SanoSwiss PCS PL 191211.docx

3971_1 Pakuotės lapelis 191211.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3122/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Paklitakselis	6 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
62499	76909	1076909	flakonas	5 ml N1		Receptinis	LT/1/16/3971/001	Netiekiama	-	-	No	-	-	Download
66572	81107	1081107	flakonas	5 ml N10		Receptinis	LT/1/16/3971/002	Netiekiama	-	-	No	-	-
66573	81108	1081108	flakonas	16,7 ml N1		Receptinis	LT/1/16/3971/003	Netiekiama	-	-	No	-	-
66574	81109	1081109	flakonas	50 ml N1		Receptinis	LT/1/16/3971/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2018-10-08	Perregistruotas
2016-09-26	Registruotas