Colobreathe

Medicinal product

(Invented) name

Colobreathe

Active substance (s)

Kolistimetato natrio druska

Strength

1662500 TV

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XB01, Colistin

Marketing authorisation holder

Essential Pharma Limited, Malta

Date of authorisation

2012-02-13

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder, hard capsule	1 vnt.
Kolistimetato natrio druska	1662500 TV

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
51238	65130	1065130	lizdinė plokštelė	N56 (4x14) +Turbospin inhaliatorius		Receptinis	EU/1/11/747/001	Netiekiama	-	-	No	-	-
60569	74853	1074853	lizdinė plokštelė	N8 (1x8) + Turbospin inhaliatorius		Receptinis	EU/1/11/747/002	Netiekiama	-	-	No	-	-
60570	74854	1074854	lizdinė plokštelė	N56 (7x8) +Turbospin inhaliatorius		Receptinis	EU/1/11/747/003	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-02-13	Registruotas