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 |
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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 |
|
|
|
|
|
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|
Notes |
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|
(6) Specify name of non Article 5 importing party |
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|
|
For Article 5 Parties : YES or NO |
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