Ganirelix Gedeon Richter

Medicinal product

(Invented) name

Ganirelix Gedeon Richter

Active substance (s)

Ganireliksas

Strength

0,25 mg/0,5 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2022-07-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	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
109011	95117	1095117	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/22/1658/001	Tiekiama	2025-04-01	-	No	-	-
109012	95118	1095118	užpildytas švirkštas	0,5 ml N6		Receptinis	EU/1/22/1658/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Registruotas