Orgalutran

Medicinal product

(Invented) name

Orgalutran

Active substance (s)

Ganireliksas

Strength

0,25 mg/0,5 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)

H01CC01, Ganirelix

Marketing authorisation holder

N.V. Organon, Nyderlandai

Date of authorisation

2000-05-17

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

solution for injection	0.5 ml
Ganireliksas	0,25 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
4684	10028	1010028	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/00/130/001	Netiekiama	-	-	No	-	-
4685	10029	1010029	užpildytas švirkštas	0,5 ml N5		Receptinis	EU/1/00/130/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-05-17	Registruotas