Nordimet

Medicinal product

(Invented) name

Nordimet

Active substance (s)

Metotreksatas

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX03, Methotrexate

Marketing authorisation holder

Nordic Group BV, Nyderlandai

Date of authorisation

2016-08-18

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

Solution for injection in pre-filled syringe	1 ml
Metotreksatas	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
98226	84324	1084324	užpildytas švirkštas	1 ml N1 ir 2 tamponai		Receptinis	EU/1/16/1124/046	Netiekiama	-	-	No	-	-
98227	84325	1084325	užpildytas švirkštas	1 ml N4 (4x1) ir 8 (4x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/047	Netiekiama	-	-	No	-	-
101253	87360	1087360	užpildytas švirkštas	1 ml N12 (12x1) ir 24 (12x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/056	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-18	Registruotas