gammanorm

Medicinal product

(Invented) name

gammanorm

Active substance (s)

Žmogaus normalusis imunoglobulinas

Strength

165 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis, 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

2011-01-26

Date of renewal

2015-04-22

Documents

2308_1_18 gammanorm RPP 201015.docx

2308_1_18 Pakuotės lapelis 201015.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0390/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Žmogaus normalusis imunoglobulinas	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
41539	55298	1055298	flakonas	10 ml N1		Receptinis	LT/1/10/2308/001	Netiekiama	-	-	No	-	-	Download
41540	55299	1055299	flakonas	10 ml N10		Receptinis	LT/1/10/2308/002	Netiekiama	-	-	No	-	-
44554	58350	1058350	flakonas	10 ml N20		Receptinis	LT/1/10/2308/003	Netiekiama	-	-	No	-	-
44555	58351	1058351	flakonas	20 ml N1		Receptinis	LT/1/10/2308/004	Netiekiama	-	-	No	-	-
44556	58352	1058352	flakonas	20 ml N10		Receptinis	LT/1/10/2308/005	Netiekiama	-	-	No	-	-
44557	58353	1058353	flakonas	20 ml N20		Receptinis	LT/1/10/2308/006	Netiekiama	-	-	No	-	-
58899	73116	1073116	flakonas	6 ml N1		Receptinis	LT/1/10/2308/007	Netiekiama	-	-	No	-	-
58900	73117	1073117	flakonas	6 ml N10		Receptinis	LT/1/10/2308/008	Netiekiama	-	-	No	-	-
58901	73118	1073118	flakonas	6 ml N20		Receptinis	LT/1/10/2308/009	Netiekiama	-	-	No	-	-
58902	73119	1073119	flakonas	12 ml N1		Receptinis	LT/1/10/2308/010	Netiekiama	-	-	No	-	-
58903	73120	1073120	flakonas	12 ml N10		Receptinis	LT/1/10/2308/011	Netiekiama	-	-	No	-	-
58904	73121	1073121	flakonas	12 ml N20		Receptinis	LT/1/10/2308/012	Netiekiama	-	-	No	-	-
58905	73122	1073122	flakonas	24 ml N1		Receptinis	LT/1/10/2308/013	Netiekiama	-	-	No	-	-
58906	73123	1073123	flakonas	24 ml N10		Receptinis	LT/1/10/2308/014	Netiekiama	-	-	No	-	-
58907	73124	1073124	flakonas	24 ml N20		Receptinis	LT/1/10/2308/015	Netiekiama	-	-	No	-	-
58908	73125	1073125	flakonas	48 ml N1		Receptinis	LT/1/10/2308/016	Netiekiama	-	-	No	-	-
58909	73126	1073126	flakonas	48 ml N10		Receptinis	LT/1/10/2308/017	Netiekiama	-	-	No	-	-
58910	73127	1073127	flakonas	48 ml N20		Receptinis	LT/1/10/2308/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-04-22	Perregistruotas
2011-01-26	Registruotas