Nordimet

Medicinal product

(Invented) name

Nordimet

Active substance (s)

Metotreksatas

Strength

10 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	0.4 ml
Metotreksatas	10 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
98208	84306	1084306	užpildytas švirkštas	0,4 ml N1 ir 2 tamponai		Receptinis	EU/1/16/1124/028	Netiekiama	-	-	No	-	-
98209	84307	1084307	užpildytas švirkštas	0,4 ml N4 (4x1) ir 8 (4x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/029	Netiekiama	-	-	No	-	-
101247	87354	1087354	užpildytas švirkštas	0,4 ml N12 (12x1) ir 24 (12x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/050	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-18	Registruotas