Yuflyma

Medicinal product

(Invented) name

Yuflyma

Active substance (s)

Adalimumabas

Strength

80 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

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

Yuflyma paciento priminimo kortele vaikams.pdf

Yuflyma paciento priminimo kortele.pdf

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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 pen	0.8 ml
Adalimumabas	80 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
108231	94335	1094335	užpildytas švirkštiklis	N1 (ir 2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/20/1513/015	Tiekiama	-	-	No	-	-
108232	94336	1094336	užpildytas švirkštiklis	N3 (ir 4 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/20/1513/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas