Nordimet

Medicinal product

(Invented) name

Nordimet

Active substance (s)

Metotreksatas

Strength

15 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	0.6 ml
Metotreksatas	15 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
98214	84312	1084312	užpildytas švirkštas	0,6 ml N1 ir 2 tamponai		Receptinis	EU/1/16/1124/034	Netiekiama	-	-	No	-	-
98215	84313	1084313	užpildytas švirkštas	0,6 ml N4 (4x1) ir 8 (4x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/035	Netiekiama	-	-	No	-	-
101249	87356	1087356	užpildytas švirkštas	0,6 ml N12 (12x1) ir 24 (12x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/052	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-18	Registruotas