Idacio

Medicinal product

(Invented) name

Idacio

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

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2019-04-02

Date of renewal

Documents

Idacio pediatrinio paciento priminimo kortelė.pdf

Idacio suaugusio paciento priminimo kortelė.pdf

Search in EMA Europe

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	0.8 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
101384	87487	1087487	užpildytas švirkštas	0,8 ml N2 (ir 2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1356/002	Netiekiama	-	-	No	-	-
102332	88432	1088432	užpildytas švirkštas	0,8 ml N6 (ir 6 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1356/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-02	Registruotas