Humira

Medicinal product

(Invented) name

Humira

Active substance (s)

Adalimumabas

Strength

40 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)

L04AB04, Adalimumab

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2003-09-08

Date of renewal

Documents

Humira paciento priminimo kortele vaikams.pdf

Humira paciento priminimo kortele suaugusiems.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	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
64388	78871	1078871	užpildytas švirkštas	0,4 ml ir alkoholiu suvilgytas tamponas N1		Receptinis	EU/1/03/256/012	Netiekiama	-	-	No	-	-
64389	78872	1078872	užpildytas švirkštas	0,4 ml ir alkoholiu suvilgytas tamponas N2		Receptinis	EU/1/03/256/013	Netiekiama	-	-	No	-	-
64390	78873	1078873	užpildytas švirkštas	0,4 ml ir alkoholiu suvilgytas tamponas N4		Receptinis	EU/1/03/256/014	Netiekiama	-	-	No	-	-
64391	78874	1078874	užpildytas švirkštas	0,4 ml ir alkoholiu suvilgytas tamponas N6		Receptinis	EU/1/03/256/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-09-08	Registruotas