Pemetrexed Accord

Medicinal product

(Invented) name

Pemetrexed Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2016-01-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	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
105409	91509	1091509	flakonas	4 ml N1		Receptinis	EU/1/15/1071/004	Netiekiama	-	-	No	-	-
105410	91510	1091510	flakonas	20 ml N1		Receptinis	EU/1/15/1071/005	Tiekiama	2025-08-02	-	No	-	-
105411	91511	1091511	flakonas	34 ml N1		Receptinis	EU/1/15/1071/006	Netiekiama	-	-	No	-	-
105412	91512	1091512	flakonas	40 ml N1		Receptinis	EU/1/15/1071/007	Netiekiama	2025-07-11	2026-06-30	Yes	2025-07-21	2026-06-30

Stadijos

Data	Stadija
2016-01-18	Registruotas