Saphnelo

Medicinal product

(Invented) name

Saphnelo

Active substance (s)

Anifrolumabas

Strength

120 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)

L04AG11, anifrolumab

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2022-02-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Užpildytame švirkštiklyje (0,8 ml tirpalo) yra	0.8 ml
Anifrolumabas	120 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
119446	105550	1105550	užpildytas švirkštiklis	N1		Receptinis	EU/1/21/1623/003	Netiekiama	-	-	No	-	-
119936	106042	1106042	užpildytas švirkštiklis	N4		Receptinis	EU/1/21/1623/004	Netiekiama	-	-	No	-	-
119937	106043	1106043	užpildytas švirkštiklis	N12 (3×4)		Receptinis	EU/1/21/1623/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-14	Registruotas