Idacio

Medicinal product

(Invented) name

Idacio

Active substance (s)

Adalimumabas

Strength

40 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

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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 pen	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
101385	87488	1087488	užpildytas švirkštiklis	0,8 ml N2 (ir 2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1356/003	Tiekiama	-	-	No	-	-
102333	88433	1088433	užpildytas švirkštiklis	0,8 ml N6 (6 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/19/1356/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-02	Registruotas