Pombiliti

Medicinal product

(Invented) name

Pombiliti

Active substance (s)

Cipagliukozidazė alfa

Strength

105 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB23, cipaglucosidase alfa

Marketing authorisation holder

Amicus Therapeutics Europe Limited, Airija

Date of authorisation

2023-03-20

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

Powder for concentrate for solution for infusion	1 vnt.
Cipagliukozidazė alfa	105 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
110724	96835	1096835	flakonas	N1		Receptinis	EU/1/22/1714/001	Netiekiama	-	-	No	-	-
110725	96836	1096836	flakonas	N10		Receptinis	EU/1/22/1714/002	Netiekiama	-	-	No	-	-
110726	96837	1096837	flakonas	N25		Receptinis	EU/1/22/1714/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-20	Registruotas