Ovaleap

Medicinal product

(Invented) name

Ovaleap

Active substance (s)

Folitropinas alfa

Strength

300 TV/0,5 ml

Pharmaceutical form

injekcinis tirpalas

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

Theramex Ireland Limited, Airija

Date of authorisation

2013-09-27

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	0.5 ml
Folitropinas alfa	300 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
57463	71579	1071579	užtaisas	N1 ir 10 adatų		Receptinis	EU/1/13/871/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-27	Registruotas