Intrarosa

Medicinal product

(Invented) name

Intrarosa

Active substance (s)

Prasteronas

Strength

6,5 mg

Pharmaceutical form

ovulės

Route (s) of administration

vartoti į makštį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03XX01, prasterone

Marketing authorisation holder

Endoceutics S.A., Belgija

Date of authorisation

2018-01-08

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

Ovule	1 vnt.
Prasteronas	6,5 mg

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
98972	85076	1085076	lizdinė plokštelė	N28 ir 6 aplikatoriai		Receptinis	EU/1/17/1255/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas