Pemetrexed Viatris [Pemetrexed Mylan]

Medicinal product

(Invented) name

Pemetrexed Viatris [Pemetrexed Mylan]

Active substance (s)

Pemetreksedas

Strength

25 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)

L01BA04, Pemetrexed

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2018-02-07

Date of renewal

2022-07-08

Documents

4196 Pakuotės lapelis 2024 12 20.docx

4196 Pemetrexed Viatris PCS PL 2024 12 20.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

IE/H/1346/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra:	1 ml
Pemetreksedas	25 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
98898	85002	1085002	flakonas	4 ml N1		Receptinis	LT/1/18/4196/001	Netiekiama	-	-	No	-	-
98899	85003	1085003	flakonas	20 ml N1		Receptinis	LT/1/18/4196/002	Netiekiama	-	-	No	-	-	Download
98900	85004	1085004	flakonas	40 ml N1		Receptinis	LT/1/18/4196/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-08	Perregistruotas
2018-02-07	Registruotas