Amsparity

Medicinal product

(Invented) name

Amsparity

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

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 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
103326	89428	1089428	užpildytas švirkštiklis	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/19/1415/007	Netiekiama	-	-	No	-	-
103327	89429	1089429	užpildytas švirkštiklis	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/19/1415/008	Netiekiama	-	-	No	-	-
103328	89430	1089430	užpildytas švirkštiklis	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N4		Receptinis	EU/1/19/1415/009	Netiekiama	-	-	No	-	-
103329	89431	1089431	užpildytas švirkštiklis	0,8 ml tirpalo ir 2 alkoholiu suvilgyti tamponai N6		Receptinis	EU/1/19/1415/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-02-13	Registruotas