Berotec N

Medicinal product

(Invented) name

Berotec N

Active substance (s)

Fenoterolio hidrobromidas

Strength

100 µg/išpurškime

Pharmaceutical form

suslėgtasis įkvepiamasis tirpalas

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AC04, Fenoterol

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2000-03-06

Date of renewal

2013-04-11

Documents

0464 Berotec N PCS PL 2023 10 05.docx

0464 Pakuotės lapelis 2023 10 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kiekviename išpurškime yra	1 išpurškime
Fenoterolio hidrobromidas	100 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
17168	3787	1003787	slėginė talpyklė	200 išpurškimų N1		Receptinis	LT/1/2000/0464/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2013-04-11	Perregistruotas
2000-03-06	Registruotas