Bemfola

Medicinal product

(Invented) name

Bemfola

Active substance (s)

Folitropinas alfa

Strength

225 TV/0,375 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	0.375 ml
Folitropinas alfa	225 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
58942	73160	1073160	užpildytas švirkštiklis	0,375 ml, adata N1		Receptinis	EU/1/13/909/003	Tiekiama	-	-	No	-	-
60859	75149	1075149	užpildytas švirkštiklis	0,375 ml, adata N5		Receptinis	EU/1/13/909/010	Netiekiama	-	-	No	-	-
60860	75150	1075150	užpildytas švirkštiklis	0,375 ml, adata N10		Receptinis	EU/1/13/909/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-27	Registruotas