Methotrexate Accord

Medicinal product

(Invented) name

Methotrexate Accord

Active substance (s)

Metotreksatas

Strength

25 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti į arteriją, leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01BA01, Methotrexate

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2012-08-02

Date of renewal

2021-11-18

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1205/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Metotreksatas	25 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
50636	64523	1064523	flakonas	2 ml N1	Receptinis	LT/1/12/3024/001	Netiekiama	-	-	No	-	-	Download
53109	67051	1067051	flakonas	20 ml N1	Receptinis	LT/1/12/3024/002	Netiekiama	-	-	No	-	-
53110	67052	1067052	flakonas	20 ml N10	Receptinis	LT/1/12/3024/003	Netiekiama	-	-	No	-	-
53111	67053	1067053	flakonas	40 ml N1	Receptinis	LT/1/12/3024/004	Netiekiama	2024-12-16	-	No	-	-
53112	67054	1067054	flakonas	40 ml N10	Receptinis	LT/1/12/3024/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-18	Perregistruotas
2012-08-02	Registruotas