cutaquig

Medicinal product

(Invented) name

cutaquig

Active substance (s)

Žmogaus normalusis imunoglobulinas (poodinis)

Strength

165 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BA01, Immunoglobulins, normal human, for extravascular adm.

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2022-02-03

Date of renewal

2024-04-30

Documents

4893 pakuotes lapelis_2024-04-30.docx

4893 cutaquig_perr2024-04-30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4903/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Žmogaus normalusis imunoglobulinas (poodinis)	165 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
108007	94112	1094112	flakonas	6 ml N1		Receptinis	LT/1/22/4893/001	Netiekiama	-	-	No	-	-
108008	94113	1094113	flakonas	6 ml N10		Receptinis	LT/1/22/4893/002	Netiekiama	-	-	No	-	-
108009	94114	1094114	flakonas	6 ml N20		Receptinis	LT/1/22/4893/003	Netiekiama	-	-	No	-	-
108010	94115	1094115	flakonas	10 ml N1		Receptinis	LT/1/22/4893/004	Netiekiama	-	-	No	-	-
108011	94116	1094116	flakonas	10 ml N10		Receptinis	LT/1/22/4893/005	Netiekiama	-	-	No	-	-
108012	94117	1094117	flakonas	10 ml N20		Receptinis	LT/1/22/4893/006	Netiekiama	-	-	No	-	-
108013	94118	1094118	flakonas	12 ml N1		Receptinis	LT/1/22/4893/007	Tiekiama	-	-	No	-	-
108015	94119	1094119	flakonas	12 ml N10		Receptinis	LT/1/22/4893/008	Netiekiama	-	-	No	-	-
108016	94120	1094120	flakonas	12 ml N20		Receptinis	LT/1/22/4893/009	Netiekiama	-	-	No	-	-
108017	94121	1094121	flakonas	20 ml N1		Receptinis	LT/1/22/4893/010	Netiekiama	-	-	No	-	-
108018	94122	1094122	flakonas	20 ml N10		Receptinis	LT/1/22/4893/011	Netiekiama	-	-	No	-	-
108019	94123	1094123	flakonas	20 ml N20		Receptinis	LT/1/22/4893/012	Netiekiama	-	-	No	-	-
108020	94124	1094124	flakonas	24 ml N1		Receptinis	LT/1/22/4893/013	Tiekiama	-	-	No	-	-
108021	94125	1094125	flakonas	24 ml N10		Receptinis	LT/1/22/4893/014	Netiekiama	-	-	No	-	-
108022	94126	1094126	flakonas	24 ml N20		Receptinis	LT/1/22/4893/015	Netiekiama	-	-	No	-	-
108023	94127	1094127	flakonas	48 ml N1		Receptinis	LT/1/22/4893/016	Netiekiama	-	-	No	-	-
108024	94128	1094128	flakonas	48 ml N10		Receptinis	LT/1/22/4893/017	Netiekiama	-	-	No	-	-
108025	94129	1094129	flakonas	48 ml N20		Receptinis	LT/1/22/4893/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-30	Perregistruotas
2022-02-03	Registruotas