ROMANIA – MINISTRY OF WATERS AND ENVIRONMENTAL PROTECTION

 

Party

Device (CFC MDI, HFC MDI, or DPI)

Active Ingredient(s)

Brand Name

Manufacture

Source Party

Date Authorized for Marketing (if applicable)

Data Approved

Date Launched

Romania

CFC MDI

Beclometasone dipropionate

Beclocort forte Inhaler 250 meg/dose

GlaxoSmithKline

Poland,Poznan

02.03.1995

Will be discontinued starting with 01.01.2006

01.09.1995

Romania

CFC MDI

Beclometasone dipropionate

Beclocort forte Inhaler 250 meg/dose

GlaxoSmithKline

Speke, UK

14.05.1991

Will be discontinued starting with 01.01.2006

01.11.1991

Romania

CFC MDI

Beclometasone dipropionate

Beclocort forte Inhaler 50 meg/dose

GlaxoSmithKline

Poland, Poznan

02.03.1995

Will be discontinued starting with 01.01.2006

01.09.1995

Romania

CFC MDI

Beclometasone dipropionate

Beclocort forte Inhaler 50 meg/dose

GlaxoSmithKline

Speke, UK

14.05.1991

30.09.1991;Will be discontinued starting with 01.01.2006

01.11.1991

Romania

CFC MDI

Fluticasone propionate

Flixotide Inhaler 25 meg/dos

GlaxoSmithKline

Speke, UK

11.08.1995

01.10.1995

01.02.1996

Romania

CFC MDI

Fluticasone propionate

Flixotide Inhaler 50 meg/dos

GlaxoSmithKline

Speke, UK

11.08.1995

01.10.1995

01.02.1996

Romania

CFC MDI

Fluticasone propionate

Flixotide Inhaler

– CFC Free

125  meg/dos

GlaxoSmithKline

France, Evreaux

24.10.2002

Pending

01.08.2003

Romania

CFC MDI

Fluticasone propionate

Flixotide Inhaler -

CFC free

250 meg/dos

GlaxoSmithKline

Poland, Poznan

24.10.2002

Pending

01.08.2003