Fomeda Easyhaler

Medicinal product

(Invented) name

Fomeda Easyhaler

Active substance (s)

Formoterolio fumaratas dihidratas

Strength

12 µg/dozėje

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AC13, Formoterol

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2006-01-18

Date of renewal

2012-01-27

Documents

0396 pakuotes lapelis 2023 09 18.docx

0396 Fomeda Easyhaler PL 2023 09 18, VRA_16616.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

FI/H/0448/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Vienoje išmatuotoje dozėje yra	1 dozėje
Formoterolio fumaratas dihidratas	12 µg

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
15228	4443	1004443	inhaliatorius	daugiadozis inhaliatorius (120 dozių) N1		Receptinis	LT/1/05/0396/001	Netiekiama	-	-	No	-	-	Download
15229	19415	1019415	inhaliatorius	daugiadozis inhaliatorius (120 dozių) N2		Receptinis	LT/1/05/0396/002	Netiekiama	-	-	No	-	-
15230	19416	1019416	inhaliatorius	daugiadozis inhaliatorius su apsauginiu dangteliu (120 dozių) N1		Receptinis	LT/1/05/0396/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-01-27	Perregistruotas
2006-01-18	Registruotas