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

UAB Niromed, Lietuva

Date of authorisation

2025-06-25

Date of renewal

Documents

2665_Berotec N 100mcg_susl_įkv_tirp_PL_2025-06-25.docx

2665_Berotec N 100mcg_susl_įkv_tirp_PZ_2025-06-25.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
117871	103976	1103976	slėginė talpyklė	200 išpurškimų N1		Receptinis	LT/L/25/2665/001	Tiekiama	2025-08-30	-	No	-	-	Download
117872	103977	1103977	slėginė talpyklė	200 išpurškimų N3		Receptinis	LT/L/25/2665/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-25	Registruotas