Ammily

Medicinal product

(Invented) name

Ammily

Active substance (s)

Dienogestas/Etinilestradiolis

Strength

2 mg/0,03 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AA16, Dienogest and ethinylestradiol

Marketing authorisation holder

UAB Orivas, Lietuva

Date of authorisation

2009-04-10

Date of renewal

2021-12-13

Documents

1524 Pakuotės lapelis 2024 12 18.docx

1524 Ammily PCS II PL 2024 12 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0168/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Dienogestas	2 mg
Etinilestradiolis	0,03 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
23546	26240	1026240	lizdinė plokštelė	N21		Receptinis	LT/1/09/1524/001	Tiekiama	-	-	No	-	-	Download
34993	37333	1037333	lizdinė plokštelė	N3x21		Receptinis	LT/1/09/1524/002	Netiekiama	-	-	No	-	-
34994	37334	1037334	lizdinė plokštelė	N6x21		Receptinis	LT/1/09/1524/003	Netiekiama	-	-	No	-	-
56636	70736	1070736	lizdinė plokštelė	N13x21		Receptinis	LT/1/09/1524/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-13	Perregistruotas
2009-04-10	Registruotas