Hulio

Medicinal product

(Invented) name

Hulio

Active substance (s)

Adalimumabas

Strength

40 mg/0,8 ml

Pharmaceutical form

injekcinis tirpalas

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

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2018-09-17

Date of renewal

Documents

Hulio paciento kortele suaugusiems.pdf

Hulio paciento kortele vaikams.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	0.8 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
100118	86227	1086227	flakonas	N2: (2x1) flakonai, 2 (2x1) švirkštai, (2x1) adatos, 2 (2x1) flakono adapteriai ir 4 (2x2) alkoholiu suvilgyti tamponai (sudėtinė pakuotė)		Receptinis	EU/1/18/1319/007	Netiekiama	-	-	No	-	-
100946	87057	1087057	flakonas	švirkštas, adata, flakono adapteris ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/18/1319/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-17	Registruotas