Bisramex

Medicinal product

(Invented) name

Bisramex

Active substance (s)

Ramiprilis/Bizoprololio fumaratas

Strength

5 mg/2,5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09BX05, ramipril and bisoprolol

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2025-04-07

Date of renewal

Documents

5749-5750-5751-5752_Bisramex.docx

5749-50-51-52_pakuotes lapelis_2025-04-07.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

PL/H/0757/003/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Ramiprilis	5 mg
Bizoprololio fumaratas	2,5 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
117119	103219	1103219	lizdinė plokštelė	N10		Receptinis	LT/1/25/5749/001	Netiekiama	-	-	No	-	-
117120	103220	1103220	lizdinė plokštelė	N30		Receptinis	LT/1/25/5749/002	Netiekiama	-	-	No	-	-
117121	103221	1103221	lizdinė plokštelė	N60		Receptinis	LT/1/25/5749/003	Netiekiama	-	-	No	-	-
117122	103222	1103222	lizdinė plokštelė	N100		Receptinis	LT/1/25/5749/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-07	Registruotas