Armisarte

Medicinal product

(Invented) name

Armisarte

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2016-01-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

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
64859	79349	1079349	flakonas	4 ml N1		Receptinis	EU/1/15/1063/001	Netiekiama	-	-	No	-	-
64860	79350	1079350	flakonas	20 ml N1		Receptinis	EU/1/15/1063/002	Netiekiama	-	-	No	-	-
64861	79351	1079351	flakonas	40 ml N1		Receptinis	EU/1/15/1063/003	Netiekiama	-	-	No	-	-
98828	84932	1084932	flakonas	34 ml N1		Receptinis	EU/1/15/1063/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-18	Registruotas