Humira

Medicinal product

(Invented) name

Humira

Active substance (s)

Adalimumabas

Strength

80 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	0.8 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
68052	82614	1082614	užpildytas švirkštas	0,8 ml ir alkoholiu suvilgytas tamponas N1		Receptinis	EU/1/03/256/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-09-08	Registruotas