Elfabrio

Medicinal product

(Invented) name

Elfabrio

Active substance (s)

Pegunigalsidazė alfa

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB20, pegunigalsidase alfa

Marketing authorisation holder

Chiesi Farmaceutici S.p.A., Italija

Date of authorisation

2023-05-04

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

Concentrate for solution for infusion	1 ml
Pegunigalsidazė alfa	2 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
110980	97091	1097091	flakonas	10 ml N1		Receptinis	EU/1/23/1724/001	Tiekiama	2025-10-10	-	No	-	-
110981	97092	1097092	flakonas	10 ml N5		Receptinis	EU/1/23/1724/002	Netiekiama	-	-	No	-	-
110982	97093	1097093	flakonas	10 ml N10		Receptinis	EU/1/23/1724/003	Netiekiama	-	-	No	-	-
115698	101801	1101801	flakonas	2,5 ml N1		Receptinis	EU/1/23/1724/004	Nepradėtas tiekti	-	-	No	-	-
115699	101802	1101802	flakonas	2,5 ml N5		Receptinis	EU/1/23/1724/005	Nepradėtas tiekti	-	-	No	-	-
115700	101803	1101803	flakonas	2,5 ml N10		Receptinis	EU/1/23/1724/006	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-04	Registruotas