Yuflyma

Medicinal product

(Invented) name

Yuflyma

Active substance (s)

Adalimumabas

Strength

40 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	0.4 ml
Adalimumabas	40 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
106008	92109	1092109	užpildytas švirkštiklis	0,4 ml ir 2 tamponai N1		Receptinis	EU/1/20/1513/009	Tiekiama	-	-	No	-	-
106009	92110	1092110	užpildytas švirkštiklis	0,4 ml ir tamponas N2		Receptinis	EU/1/20/1513/010	Tiekiama	-	-	No	-	-
106010	92111	1092111	užpildytas švirkštiklis	0,4 ml ir tamponas N4		Receptinis	EU/1/20/1513/011	Netiekiama	-	-	No	-	-
106011	92112	1092112	užpildytas švirkštiklis	0,4 ml ir tamponas N6		Receptinis	EU/1/20/1513/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas