octagam

Medicinal product

(Invented) name

octagam

Active substance (s)

Žmogaus normalusis imunoglobulinas, intraveninis

Strength

50 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BA02, Immunoglobulins, normal human, for intravascular adm.

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2018-10-26

Date of renewal

2023-05-29

Documents

4289 Pakuotės lapelis 2025 05 28.docx

4289 octagam 50 RPP 2025 05 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4907/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Žmogaus normalusis imunoglobulinas, intraveninis	50 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
100392	86501	1086501	flakonas	20 ml N1		Receptinis	LT/1/18/4289/001	Netiekiama	-	-	No	-	-
100393	86502	1086502	buteliukas	50 ml N1		Receptinis	LT/1/18/4289/002	Netiekiama	-	-	No	-	-
100394	86503	1086503	buteliukas	100 ml N1		Receptinis	LT/1/18/4289/003	Netiekiama	-	-	No	-	-
100395	86504	1086504	buteliukas	200 ml N1		Receptinis	LT/1/18/4289/004	Netiekiama	-	-	No	-	-
100396	86505	1086505	buteliukas	200 ml N2		Receptinis	LT/1/18/4289/005	Netiekiama	-	-	No	-	-
100397	86506	1086506	buteliukas	200 ml N3		Receptinis	LT/1/18/4289/006	Netiekiama	-	-	No	-	-
100398	86507	1086507	buteliukas	500 ml N1		Receptinis	LT/1/18/4289/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-29	Perregistruotas
2018-10-26	Registruotas