Bemfola

Medicinal product

(Invented) name

Bemfola

Active substance (s)

Folitropinas alfa

Strength

75 TV/0,125 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2014-03-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in a pre-filled pen	0.125 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
55518	69567	1069567	užpildytas švirkštiklis	0,125 ml, adata N1		Receptinis	EU/1/13/909/001	Tiekiama	-	-	No	-	-
60855	75145	1075145	užpildytas švirkštiklis	0,125 ml, adata N5		Receptinis	EU/1/13/909/006	Netiekiama	-	-	No	-	-
60856	75146	1075146	užpildytas švirkštiklis	0,125 ml, adata N10		Receptinis	EU/1/13/909/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-27	Registruotas