DATA ON CFC MDI/CFC-FREE MDI/DPI REGISTER IN MALAYSIA (AS OF DECEMBER 2003)

 

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

Malaysia

CFC MDI

Salbutamol Sulphate

Respolin 400 Inhaler 100mcg/dose

3M pharmaceuticals Pty Ltd., Thronleigh, Australia

Australia

 

4/10/1989

Jan 90

Malaysia

CFC MDI

Salbutamol Sulphate

Respolin 400 dose Autohaler

3M pharmaceuticals Pty Ltd., Thronleigh, Australia

Australia

 

28/2/1992

Apr 92

Malaysia

CFC MDI

Beclomethasone Dipropionate

Beclomet Nasal Spray 50mcg/dose

Orion Corporation, Espoo, Finland

Finland

 

1987

1987

Malaysia

CFC MDI

Beclomethasone Dipropionate

Beclomet Aerosol 250 mcg/dose

Orion Corporation, Espoo, Finland

Finland

 

1/7/1993

1995

Malaysia

CFC MDI

Sodium Cromoglycate

Intal 5 Inhaler

Holmes Chapel (Fison Ltd. UK)

UK

 

27/2/1997

1997

Malaysia

CFC MDI

Terbutaline

Bricanyl 0.25mg/dose inhaler

3 Healthcare Ltd.

UK

 

27/2/1997

1997

Malaysia

CFC MDI

Terbutaline

Bricanyl 0.25mg/dose Misthaler

3M Healthcare

UK

 

27/2/1997

1997

Malaysia

CFC MDI

Budesonide

Pulmicort 50mcg/dose inhaler

3M Healthcare

UK

 

27/2/1997

1997

Malaysia

CFC MDI

Budesonide

Pulmicort 200mcg/dose Misthaler

3M Healthcare Ltd.

UK

 

27/2/1997

1997

Malaysia

CFC MDI

Ipratropium Bromide

Atrovent MDI 20mcg/puff

Boehringer Ingelheim Pharma KG

Germany

 

 

 

Malaysia

CFC MDI

Feneterol Hydrobromide

Berotec 100mcg/puff

Boehringer Ingelheim

Germany

 

 

 

Malaysia

CFC MDI

Feneterol Hydrobromide

Berotec 200mcg/Puff

Boehringer Ingelheim Pharma KG

Germany

 

 

 

Malaysia

CFC MDI

Ipratropium Bromide & Feneterol Hydrobromide

Berodual MDI

Boehringer Ingelheim Pharma KG

Germany

 

 

 


 

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

Malaysia

CFC MDI

Ipratropium Bromide & Salbutamol

Combivent MDI

Boehringer Ingelheim France

France

 

 

 

Malaysia

CFC MDI

Budesonide

Inflammide MDI 50mcg

Ingelheim Pty Ltd.

South Africa

 

 

 

Malaysia

CFC MDI

Budesonide

Inflammide MDI 100mcg

Ingelheim Pty Ltd.

South Africa

 

 

 

Malaysia

CFC MDI

Budesonide

Inflammide MDI 200mcg

Ingelheim Pty Ltd.

South Africa

 

 

 

Malaysia

CFC MDI

Salbutamol

Butovent C Spray 100mcg/Dose

Chiesi Farmaceutici SPA

Italy

26/6/1997

26/6/1997

24/3/1998

Malaysia

CFC MDI

Beclomethasone Dipropionate

Clenil Forte Spray 250mcg/Dose

Chiesi Farmaceutici SPA

Italy

24/7/1997

24/7/1997

31/3/1998

Malaysia

CFC MDI

Beclomethasone Dipropionate

Clenil Metered Inhaler 50mcg/dose

Chiesi Farmaceutici SPA

Italy

29/12/1997

19/12/1997

8/9/1998

Malaysia

CFC MDI

Beclomethasone Dipropionate

Becotide/Becloforte

GlaxosmithKline, Speke

UK

 

30/4/1987

1985

Malaysia

CFC MDI

Fluticasone Propionate

Flixotide

Glaxosmithkline, Speke

UK

 

1/10/1995

15/12/1996

Malaysia

CFC MDI

Salmeterol Xinafoate

Serevent

Glaxosmithkline, Speke

UK

 

15/2/1995

1995

Malaysia

CFC MDI

Beclomethasone Dipropionate

Beclate 50 Inhaler, 200 doses

CIPLA ltd. India

India

NA

 

Mar 01

Malaysia

CFC MDI

Salbutamol Sulphate

Asthalin Inhaler 100mcg, 200 doses

CIPLA Ltd.

India

NA

 

 

Malaysia

CFC MDI

Salbutamol

Salbutamol 0.10 mg/dose Inhaler

Norton (Waterford) Ltd.

Ireland

NA

NA

NA

Malaysia

CFC MDI

Salbutamol

Butahale Inhaler 100mcg/Dose

Dr. Reddy’s Laboratories, Andhra Pradesh

India

 

6/8/1998

Nov. 98

Malaysia

CFC MDI

Beclomethasone Dipropionate

Beclomet Aerosol 50mcg/Dose

Orion Corporation Espoo, Finland

Finland

 

1987

1987

Malaysia

 

 

CFC MDI

Beclomethasone Dipropionate

Beclomet Easyhaler Inhalation Powder 200mcg/Dose

Orion Corporation Espoo

Finland

 

31/1/1997

Aug 97

Malaysia

CFC MDI

Salbutamol

Buventol Easyhaler Inhalation Powder 100mcg/Dose

Orion Corporation Espoo

Finland

 

17/10/1996

Aug 97


 

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

Malaysia

CFC MDI

Terbutaline

Bricanyl Turbuhaler 0.5mg/Dose

Astra Zeneca AB Sodertalje

Sweden

27/2/1997

 

1987

Malaysia

CFC MDI

Budesonide

Pulmicort Turbuhaler 100mcg/Dose

Astra Zeneca AB Sodertalje

Sweden

1/6/1991

 

1991

Malaysia

CFC MDI

Budesonide

Pulmicort

Astra Zeneca AB Sodertalje

Sweden

1/6/1991

 

1991

Malaysia

DPI

Budesonide & Formoterol Fumarate

Symbicort Turbuhaler 80/r.5 mcg/Dose

Astra Zeneca AB Sodertalje

Sweden

20/6/2002

 

2002

Malaysia

DPI

Budesonide & Formoterol Fumarate

Symbicort Turbuhaler 160ug/Dose

Astra Zeneca AB Sodertalje

Sweden

20/6/2002

 

2002

Malaysia

DPI

Budesonide & Formoterol Fumarate

Oxis Turbuhaler 4.5UG/Dose

Astra Zeneca AB Sodertalje

Sweden

27/5/1999

 

1999

Malaysia

DPI

Budesonide & Formoterol Fumarate

Oxis Turbuhaler 9UG/Dose

Astra Zeneca AB Sodertalje

Sweden

27/5/1999

 

1999

Malaysia

DPI

Tiotropium

Spririva 0.225mg/capsule

Boehringer Ingelheim Pharma KG

Germany

22/4/2003

 

Launched

Malaysia

DPI

Beclomethasone Dipropionate

Becotide

GlaxosmithKline, Boronia

Australia

 

8/2/1999

6/21/1905

Malaysia

DPI

Flutocasone Propionate & Salmeterol Xinafoate

Seretide

GlaxosmithKline, Ware

UK

 

5/10/2000

Nov 00

Malaysia

DPI

Salbutamol Sulphate

Ventolin

GlaxosmithKline,Boronia

Australia

 

11/2/1999

1999

Malaysia

DPI

Formoterol Fumarate

Foradil 12mcg Dry Powder capsule for Inhalation

Novartis Pharma Stein AG

Switzerland

6/12/1996

6/12/1996

1997

Malaysia

HFC MDI

Salbutamol Sulphate

Airomir Inhaler

3M Healthcare Ltd. Loughborough

England

 

29/8/1996

Sep 96

Malaysia

HFC MDI

Beclomethasone Dipripionate

QVAR 50 Inhaler

3M Healthcare Ltd. Loughborough

England

 

27/1/2000

Jan 01


 

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

Malaysia

HFC MDI

Beclomethasone Dipripionate

QVAR 100 Inhaler

3M Healthcare Ltd. Loughborough

England

 

27/1/2000

Jan 01

Malaysia

HFC MDI

Beclomethasone Dipripionate

QVAR 50 Autohaler

3M Healthcare Ltd. Loughborough

England

 

27/1/2000

Not marked

Malaysia

HFC MDI

Beclomethasone Dipripionate

QVAR 100 Autohaler

3M Healthcare Ltd. Loughborough

England

 

27/1/2000

Not Marked

Malaysia

HFC MDI

Beclomethasone Dipripionate

Atrovent N

Boehringer Ingelheim Pharma KG

Germany

21/8/2003

 

Will be launched

Malaysia

HFC MDI

Feneterol Hydrobromide

Berotec N

Boehringer Ingelheim Pharma KG

Germany

24/4/2001

 

1/1/2002

Malaysia

HFC MDI

Ipratropium Bromide & Feneterol Hydrobromide

Berodual N

Boehringer Ingelheim Pharma KG

Germany

29/5/2003

 

Launched

Malaysia

HFC MDI

Fluticasone Propionate

Flixotide Evohaler

GlaxosmithKline, Speke

UK

 

18/11/2002

EST 2Q2004

Malaysia

HFC MDI

Fluticasone Propionate & Salmeterol Xinafoate

Seretide Evohaler

GlaxosmithKline, Speke

UK

 

10/8/2001

Oct 01

Malaysia

 

Salbutamol Sulphate

Ventolin Evohaler

GlaxosmithKline, Speke

UK

 

27/4/2000

May 01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY

 

 

 

 

 

 

 

CFC MDI

28

 

 

 

 

 

 

 

CFC-Free MDI

11

 

 

 

 

 

 

 

DPI

15

 

 

 

 

 

 

 

Total

54

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Notes

1)      Check against worksheet list of active ingredients

2)      Source Party means the country where the product is produced

3)      Date of approval by Health Authorities – NOT APPLICABLE for CFC MDIs

4)      Date Final Approval Pricing/Reimbursement – NOT APPLICATION for CFC MDIs

5)      Date available on the market – Date NOT needed for CFC MDIs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exporting Party

Device(CFC MDI,HFC MDI or DPI)

Active Ingredients

Brand Name

Manufacturer

Importing Party (6)

Australia

CFC MDI

Salbutamol Sulphate

Respolin 400 Inhaler 100mcg/Dose

3M Pharmaceuticals Pty Ltd. Thronleigh Australia

Yes

Australia

CFC MDI

Salbutamol Sulphate

Respolin 400 Dose Autohaler

3M Pharmaceuticals Pty Ltd. Thronleigh Australia

Yes

Finland

CFC MDI

Beclomethasone Dipropionate

Beclomet Nasal Spray 50mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

CFC MDI

Beclomethasone Dipropionate

Beclomet Aerosol 250mcg/Dose

Orion Corporation, Espoo, Finland

Yes

United Kingdom

CFC MDI

Sodium Cromoglycate

Intal 5 Inhaler

Holmes Chapel (Fison Ltd. UK)

Yes

United Kingdom

CFC MDI

Terbutaline

Bricanyl 0.25mg/Dose Inhaler

3M Healthcare Ltd.

Yes

United Kingdom

CFC MDI

Terbutaline

Bricanyl 0.25mg/Dose Misthaler

3M Healthcare Ltd.

Yes

United Kingdom

CFC MDI

Budesonide

Pulmicort 50mcg/Dose Inhaler

3M Healthcare Ltd.

Yes

United Kingdom

CFC MDI

Budesonide

Pulmicort 200mcg/Dose Misthaler

3M Healthcare Ltd.

Yes

Germany

CFC MDI

Ipratropium Bromide

Atrovent MDI 20mcg/Puff

Boehringer Ingelheim Pharma KG

Yes

Germany

CFC MDI

Feneterol Hydrobromide

Berotec 100mcg/Puff

Boehringer Ingelheim Pharma KG

Yes

Germany

CFC MDI

Feneterol Hydrobromide

Berotec 200mcg/Puff

Boehringer Ingelheim Pharma KG

Yes

Germany

CFC MDI

Ipratropium Bromide & Feneterol Hydrobromide

Berodual MDI

Boehringer Ingelheim Pharma KG

Yes

France

CFC MDI

Ipratropium Bromide & Salbutamol

Combivent MDI

Boehringer Ingelheim Pharma KG

Yes

South Africa

CFC MDI

Budesonide

Inflammide MDI 50mcg

Ingelheim Pty Ltd.

Yes

South Africa

CFC MDI

Budesonide

Inflammide MDI 100mcg

Ingelheim Pty Ltd.

Yes

South Africa

CFC MDI

Budenoside

Inflammide MDI 200mcg

Ingelheim Pty Ltd.

Yes

Italy

CFC MDI

Salbutamol

Butovent C Spray 100mcg/Dose

Chiesi Farmaceutici SPA

Yes

Italy

CFC MDI

Beclomethasone Dipropionate

Clenil Forte Spray 250mcg/Dose

Chiesi Farmaceutici

Yes

Italy

CFC MDI

Beclomethasone Dipropionate

Clenil Metered Inhaler 50mcg/Dose

Chiesi Farmaceutici

Yes

United Kingdom

CFC MDI

Beclomethasone Dipropionate

Becotide/Becloforte

GlaxosmithKline, Speke

Yes

United Kingdom

CFC MDI

Fluticasone Priopionate

Flixotide

GlaxosmithKline, Speke

Yes

United Kingdom

CFC MDI

Salmeterol Xinafoate

Serevent

GlaxosmithKline, Speke

Yes

India

CFC MDI

Beclomethasone Diprionate

Beclate 50 Inhaler, 200 Doses

Cipla Ltd., India

Yes

India

CFC MDI

Salbutamol

Asthalin Inhaler

Cipla Ltd. India

Yes

Ireland

CFC MDI

Salbutamol

Salbutamol 0.10mg/Dose Inhaler

Norton (Waterford) Ltd.

Yes

India

CFC MDI

Salbutamol

Butahale Inhaler 100mcg/Dose

Dr. Reddy’s Laboratories, Andhra Pradesh

Yes

Finland

CFC MDI

Beclomethasone Dipropionate

Beclomet Aerosol 50mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

DPI

Beclomethasone Dipropionate

Beclomet Easyhaler Inhalation Powder 200mcg/Dose

Orion Corporation

Yes

Finland

DPI

Salbutamol

Buventol Easyhaler Inhalation Powder 100mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

DPI

Salbutamol

Buventol Easyhaler Inhalation Powder 200mcg/Dosemcg/Dose

Orion Corporation, Espoo, Finland

Yes

Sweden

DPI

Terbutaline

Bricanyl Turbuhaler 0.5mg/dose

Astra Zeneca AB Sodertalje, Sweden

Yes

Sweden

DPI

Budesonide

Pulmicort Turbuhaler 100mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Budesonide

Pulmicort Turbuhaler 200mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Budesonide & Formoterol Fumarate

Symbicort Turbuhaler 80/4.5mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Budesonide & Formoterol Fumarate

Symbicort Turbuhaler 160/4.5mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Formoterol Fumarate

Oxis Turbuhaler 4.5ug/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Formoterol Fumarate

Oxis Turbuhaler 9ug/Dose

Astra Zeneca AB Sodertalje

Yes

Germany

DPI

Tiotropium

Spririva 0.0225mg/capsule

Astra Zeneca AB Sodertalje

Yes

Australia

DPI

Beclomethasone Dipropionate

Becotide

GlaxosmithKline, Borona

Yes

United Kingdom

DPI

Fluticasone Propionate & Salmeterol Xinafoate

Seretide

GlaxosmithKline, Ware

Yes

Australia

DPI

Salbutamol Sulphate

Ventolin

GlaxosmithKline, Boronia

Yes

Switzerland

DPI

Formoterol Fumarate

Foradil 12mcg Dry Powder capsul for Inhalation

Novartis Phama Stein AG

Yes

England

DPI

Salbutamol Sulphate

Airomir Inhaler

3M Healthcare Limited, Loughborough

Yes

England

HFC MDI

Beclomethasone Dipriopionate

QVAR 50 Inhaler

3M Healthcare Limited

Yes

England

HFC MDI

Beclomethasone Dipriopionate

QVAR 100 Inhaler

3M Healthcare Limited

Yes

England

HFC MDI

Beclomethasone Dipriopionate

QVAR 50 Autohaler

3M Healthcare Limited

Yes

England

HFC MDI

Beclomethasone Dipriopionate

QVAR 100 Autohaler

3M Healthcare Limited

Yes

Germany

HFC MDI

Ipratropium Bromide

Atrovent N

Boehringer Ingelheim Pharma KG

Yes

Italy

CFC MDI

Salbutamol

Butovent C Spray 100mcg/Dose

Chiesi Farmaceutici SPA

Yes

Italy

CFC MDI

Beclomethasone Dipropionate

Clenil Forte Spray 250mcg/Dose

Chiesi Farmaceutici SPA

Yes

Italy

CFC MDI

Beclomethasone Dipropionate

Clenil Metered Inhaler 50mcg/Dose

Chiesi Farmaceutici SPA

Yes

United Kingdom

CFC MDI

Beclomethasone Dipropionate

Becotide/Becloforte

GlaxosmithKline, Speke

Yes

United Kingdom

CFC MDI

Fluticasone Propionate

Flixotide

GlaxosmithKline, Speke

Yes

United Kingdom

CFC MDI

Salmeterol Xinafoate

Serevent

GlaxosmithKline, Speke

Yes

India

CFC MDI

Beclomethasone Dipropionate

Beclate 50 Inhaler, 200 doses

Cipla Ltd., India

Yes

India

CFC MDI

Salbutamol Sulphate

Asthalin Inhaler 100mcg, 200 doses

Cipla Ltd., India

Yes

Ireland

CFC MDI

Salbutamol

Salbutamol 0.10 mg/Dose

Norton (Waterford) Ltd.

Yes

India

CFC MDI

Salbutamol

Butahale Inhaler 100mcg/Dose

Dr. Reddy’s Laboratories, Andhra Pradesh

Yes

Finland

CFC MDI

Beclomethasone Dipripionate

Beclomet Aerosol 50mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

DPI

Beclomethasone Dipropionate

Beclomet Easyhaler Inhalation Powder 200mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

DPI

Salbutamol

Buventol Easyhaler Inhalation Powder 200mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Finland

DPI

Salbutamol

Buventol Easyhaler Inhalation Powder 200mcg/Dose

Orion Corporation, Espoo, Finland

Yes

Sweden

DPI

Terbutaline

Bricanyl Turbuhaler 0.5mg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Budesonide

Pulmicort Turbuhaler 100mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Sweden

DPI

Budesonide

Pulmicort Turbuhaler 100mcg/Dose

Astra Zeneca AB Sodertalje

Yes

Germany

HFC MDI

Feneterol Hydrobromide

Berotec N

Boehringer Ingelheim Pharma KG

Yes

Germany

HFC MDI

Ipratropium Bromide & Feneterol Hydrobromide

Berodual N

Boehringer Ingelheim Pharma KG

Yes

United Kingdom

HFC MDI

Fluticasone Propionate

Flixotide Evohaler

GlaxosmithKline, Speke

 

United Kingdom

HFC MDI

Fluticasone Propionate & Salmeterol Xinafoate

Seretide Evohaler

GlaxosmithKline, Speke

Yes

United Kingdom

HFC MDI

Salbutamol Sulphate

Ventolin Evohaler

GlaxosmithKline, Speke

Yes

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY

 

 

 

 

 

 

 

 

 

 

 

CFC MDI

28

 

 

 

 

CFC-Free MDI

11

 

 

 

 

DPI

15

 

 

 

 

Total

54

 

 

 

 

 

 

 

 

 

 

Notes

 

 

 

 

 

(6) Specify name of non Article 5 importing party

 

 

 

 

For Article 5 Parties : YES or NO