Yuflyma

Medicinal product

(Invented) name

Yuflyma

Active substance (s)

Adalimumabas

Strength

20 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Purpose for use

vaikams

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB04, Adalimumab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2021-02-11

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	0.2 ml
Adalimumabas	20 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
112022	98137	1098137	užpildytas švirkštas	0,2 ml ir alkoholiu suvilgytas tamponas N2		Receptinis	EU/1/20/1513/017	Netiekiama	-	-	No	-	-
115206	101315	1101315	užpildytas švirkštas	0,2 ml ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/20/1513/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas