Hulio

Medicinal product

(Invented) name

Hulio

Active substance (s)

Adalimumabas

Strength

20 µg

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

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2018-09-17

Date of renewal

Documents

Hulio paciento kortele vaikams.pdf

Hulio paciento kortele suaugusiems.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 syringe	0.4 ml
Adalimumabas	20 µg

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
106593	92695	1092695	užpildytas švirkštas	0,4 ml N1 (2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/18/1319/009	Netiekiama	-	-	No	-	-
106594	92696	1092696	užpildytas švirkštas	0,4 ml N2 (2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/18/1319/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-17	Registruotas