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Berita Ubat-ubatan
August 2000

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Regulatory Control Beyond 2000
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Separate Manufacturing Facilities For Cephalosporins
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Warning Label for products - NSAID
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Registration of Products Containing Insect Repellants
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Warning for Products containing Hydroquinone
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Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)line.gif (87 bytes)
Licensing Update - June 2000
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The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000
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Additional Indications Approved for Registered Products
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GMP News
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Quality Control Training Course
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Sources of products registered with DCA As At 30.6.2000
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New Products Approved for Marketing in Malaysia
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NPCB officers to contact
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Clinical Trials

line_vertical.gif (147 bytes) line1.jpg (4914 bytes) ADDITIONAL INDICATIONS APPROVED FOR REGISTERED PRODUCTS
(February – May 2000)

 

No.

Product
(Active Ingredient)

Additional Indication

Product Registration
Holder

1. Campto 40 mg / 2 ml Injection
Campto 100 mg / 5 ml Injection
(Irinotecan Hydrochloride
Trihydrate)
Treatment of patients with advanced colorectal cancer.

- In combination with 5 – fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease

Rhone-Poulenc Rorer (M) Sdn. Bhd.
2. Lucrin Depot 3.75 mg Injection
(Leuprolide Acetate 3.75 mg)
Treatment of children with Central Precocious Puberty (CPP). Abbott Laboratories, Malaysia.
3. Esmeron Injection
50 mg / 5 ml (ampoules)
Esmeron Injection
100 mg / 10 ml (ampoules)
(Rocuronium)
Esmeron is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation and to facilitate mechanical ventilation in adults, children and infants from one month of age. Organon (M) Sdn Bhd
4. ReoPro Injection
10 mg / 5 ml
ReoPro 40 mg / 20 ml
(Abciximab 2 mg / ml)
Abciximab is indicated as an adjunct to heparin and aspirin for :-
  1. Percutaneous coronary intervention

    The prevention of ischaemic cardiac complication in patients undergoing percutaneous coronary intervention (ballon angioplasty, atherectomy and bailout stent).

  2. Unstable Angina

The short term (1-month) reduction of risk of myocardial infarction, in patients with unstable angina, not responding to full convention therapy who have been scheduled for percutaneous coronary intervention.

Eli Lilly (M) Sdn. Bhd.
5. Trexan Tablet 50 mg
(Naltrexone hydrochloride 50 mg)
In the treatment of alcohol dependence.

Trexan has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

The Boots Company (Malaysia) Sdn. Bhd.
Petaling Jaya.
6. Zoladex Depot Injection

Goserelin/GnRH Analogue 3.6 mg/depot

Assisted reproduction

Pituitary down regulation in preparation for superovulation.

Zeneca Pharma (M) Kuala Lumpur.
7. Taxol For Injection 30 mg/vial

Taxol For Injection 100 mg/vial
(Paclitaxel)

(i) Ovarian Carcinoma
  • First line therapy in combination with a platinum compound for the treatment of advanced metastatic carcinoma of the ovary.

(ii) Non-small Cell Lung Carcinoma

  • First line therapy in combination with a platinum compound for the treatment of non-small cell carcinoma of the lung in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Bristol-Myers Squibb (M) Sdn Bhd
8. Topamax Tablet 25 mg
Topamax Tablet 50 mg
Topamax Tablet 100 mg
Topamax Tablet 200 mg
(Topiramate 200 mg)
As an adjunct therapy for paediatric patients (2 years and above) with partial onset seizures. Johnson & Johnson Sdn. Bhd., Malaysia.