octagam

Medicinal product

(Invented) name

octagam

Active substance (s)

Žmogaus normalusis imunoglobulinas

Strength

100 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

2009-11-25

Date of renewal

2018-03-08

Documents

1790 Pakuotės lapelis 2025 04 01.docx

1790 octagam 10 proc RPP 2025 04 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0479/001/E001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Žmogaus normalusis imunoglobulinas	100 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
33322	35690	1035690	flakonas	20 ml N1		Receptinis	LT/1/09/1790/001	Netiekiama	-	-	No	-	-
33323	35691	1035691	buteliukas	50 ml N1		Receptinis	LT/1/09/1790/002	Netiekiama	-	-	No	-	-	Download
33324	35692	1035692	buteliukas	100 ml N1		Receptinis	LT/1/09/1790/003	Netiekiama	-	-	No	-	-
33325	35693	1035693	buteliukas	200 ml N1		Receptinis	LT/1/09/1790/004	Netiekiama	-	-	No	-	-
59178	73401	1073401	buteliukas	60 ml N1		Receptinis	LT/1/09/1790/005	Netiekiama	-	-	No	-	-
59179	73402	1073402	buteliukas	100 ml N3		Receptinis	LT/1/09/1790/006	Netiekiama	-	-	No	-	-
59180	73403	1073403	buteliukas	200 ml N3		Receptinis	LT/1/09/1790/007	Netiekiama	-	-	No	-	-
102808	88909	1088909	buteliukas	300 ml N1		Receptinis	LT/1/09/1790/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-08	Perregistruotas
2009-11-25	Registruotas