GONAL-f

Medicinal product

(Invented) name

GONAL-f

Active substance (s)

Folitropinas alfa

Strength

75 TV

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

Powder and solvent for solution for injection	1 ml
Folitropinas alfa	75 TV

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
7655	12596	1012596	flakonas	milteliai, tirpiklio užpildytas švirkštas (1 ml) N1		Receptinis	EU/1/95/001/025	Netiekiama	-	-	No	-	-
7656	12597	1012597	flakonas	milteliai, tirpiklio užpildytas švirkštas (1 ml) N5		Receptinis	EU/1/95/001/026	Netiekiama	-	-	No	-	-
7657	12598	1012598	flakonas	milteliai, tirpiklio užpildytas švirkštas (1 ml) N10		Receptinis	EU/1/95/001/027	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1995-10-20	Registruotas