GONAL-f

Medicinal product

(Invented) name

GONAL-f

Active substance (s)

Folitropinas alfa

Strength

1050 TV/1,75 ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03GA05, Follitropin alfa

Marketing authorisation holder

Merck Europe B.V., Nyderlandai

Date of authorisation

1995-10-20

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

Daugiadoziame flakone yra	1.75 ml
Folitropinas alfa	1050 TV/1,75 ml

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
6753	11802	1011802	flakonas	milteliai, tirpiklio užpildytas švirkštas (2 ml) ir 15 vienkartinių švirkštų N1		Receptinis	EU/1/95/001/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1995-10-20	Registruotas