Bemfola

Medicinal product

(Invented) name

Bemfola

Active substance (s)

Folitropinas alfa

Strength

450 TV/0,75 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	0.75 ml
Folitropinas alfa	450 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
58943	73161	1073161	užpildytas švirkštiklis	0,75 ml, adata N1		Receptinis	EU/1/13/909/005	Tiekiama	-	-	No	-	-
60863	75153	1075153	užpildytas švirkštiklis	0,75 ml, adata N5		Receptinis	EU/1/13/909/014	Netiekiama	-	-	No	-	-
60864	75154	1075154	užpildytas švirkštiklis	0,75 ml, adata N10		Receptinis	EU/1/13/909/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-27	Registruotas