Pemetrexed Zentiva [Pemetrexed Alvogen]

Medicinal product

(Invented) name

Pemetrexed Zentiva [Pemetrexed Alvogen]

Active substance (s)

Pemetreksedas

Strength

1000 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BA04, Pemetrexed

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2015-11-26

Date of renewal

2022-01-24

Documents

3843 Pemetrexed Zentiva milt PCS PL 2022 11 24.docx

3843 Pakuotės lapelis 2022 11 24.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3324/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Pemetreksedas	1000 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
60213	74486	1074486	flakonas	N1		Receptinis	LT/1/15/3843/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-28	Išregistruotas
2022-01-24	Perregistruotas
2015-11-26	Registruotas