Methotrexate Accord

Medicinal product

(Invented) name

Methotrexate Accord

Active substance (s)

Metotreksatas

Strength

100 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į raumenis, leisti į arteriją

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BA01, Methotrexate

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2014-10-10

Date of renewal

2021-11-18

Documents

3024 Methotrexate Accord 100mg II PL 2025 08 27.docx

3024 Pakuotės lapelis 100mg 2025 08 27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1205/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml tirpalo yra:	1 ml
Metotreksatas	100 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
56799	70906	1070906	flakonas	5 ml N1		Receptinis	LT/1/12/3024/006	Netiekiama	-	-	No	-	-
60393	74670	1074670	flakonas	5 ml N5		Receptinis	LT/1/12/3024/007	Netiekiama	-	-	No	-	-
60394	74671	1074671	flakonas	10 ml N1		Receptinis	LT/1/12/3024/008	Netiekiama	-	-	No	-	-
60395	74672	1074672	flakonas	10 ml N5		Receptinis	LT/1/12/3024/009	Netiekiama	-	-	No	-	-
60396	74673	1074673	flakonas	50 ml N1		Receptinis	LT/1/12/3024/010	Netiekiama	2024-12-16	-	No	-	-
60397	74674	1074674	flakonas	50 ml N5		Receptinis	LT/1/12/3024/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-18	Perregistruotas
2014-10-10	Registruotas