Ganirelix Theramex

Medicinal product

(Invented) name

Ganirelix Theramex

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

Theramex Ireland Limited, Airija

Date of authorisation

2023-02-13

Date of renewal

Documents

5122_pakuotes lapelis_2023-02-13.docx

5122_Ganirelix Theramex.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2640/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (0,5 ml) yra:	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
110411	96522	1096522	užpildytas švirkštas	0,5 ml N1		Receptinis	LT/1/23/5122/001	Netiekiama	-	-	No	-	-
110412	96523	1096523	užpildytas švirkštas	0,5 ml N5		Receptinis	LT/1/23/5122/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-13	Registruotas