Amsparity

Medicinal product

(Invented) name

Amsparity

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2020-02-13

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	0.8 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
103330	89432	1089432	užpildytas švirkštas	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/19/1415/003	Netiekiama	-	-	No	-	-
103331	89433	1089433	užpildytas švirkštas	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/19/1415/004	Netiekiama	-	-	No	-	-
103332	89434	1089434	užpildytas švirkštas	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N4		Receptinis	EU/1/19/1415/005	Netiekiama	-	-	No	-	-
103333	89435	1089435	užpildytas švirkštas	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N6		Receptinis	EU/1/19/1415/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-02-13	Registruotas