Libmyris

Medicinal product

(Invented) name

Libmyris

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2021-11-12

Date of renewal

Documents

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	0.4 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
107560	93665	1093665	užpildytas švirkštas	N1 (alkoholiu suvilgytas tamponas)		Receptinis	EU/1/21/1590/001	Netiekiama	-	-	No	-	-
107561	93666	1093666	užpildytas švirkštas	N2 (2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/21/1590/002	Netiekiama	-	-	No	-	-
107562	93667	1093667	užpildytas švirkštas	N6 (6 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/21/1590/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-12	Registruotas