Nordimet

Medicinal product

(Invented) name

Nordimet

Active substance (s)

Metotreksatas

Strength

7,5 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	0.3 ml
Metotreksatas	7,5 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
98205	84303	1084303	užpildytas švirkštas	N1 ir 2 tamponai		Receptinis	EU/1/16/1124/025	Netiekiama	-	-	No	-	-
98206	84304	1084304	užpildytas švirkštas	0,3 ml N4 (4x1) ir 8 (4x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/026	Netiekiama	-	-	No	-	-
101246	87353	1087353	užpildytas švirkštas	0,3 ml N12 (12x1) ir 24 (12x2) tamponai (sudėtinė)		Receptinis	EU/1/16/1124/049	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-18	Registruotas