Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Novartis South Africa (Pty) Ltd, Magwa Crescent West, Jukskei View, Waterfall City, Johannesburg, 2090
LAMPRENE 50 mg Soft Gelatin Capsules.
LAMPRENE 100mg Soft Gelatin Capsules.
| Pharmaceutical Form |
|---|
|
LAMPRENE 50 mg soft gelatin capsule: Spherical, brown, opaque soft gelatin capsules with no imprint on the capsules. Diameter approximately 7,2 mm. LAMPRENE 100 mg soft gelatin capsule: Brown, opaque, oblong, soft gelatin capsules. One side carries the imprint “GEIGY”, the other side carries imprint “GM” in white. Diameter approximately 6,5 mm. |
Active ingredient:
LAMPRENE 50 mg Soft Gelatin Capsules: Each capsule contains 50 mg clofazimine present as a microcrystalline suspension in an oil-wax base.
LAMPRENE 100 mg Soft Gelatin Capsules: Each capsule contains 100 mg micronised clofazimine suspended in an oil-wax base.
Sugar free.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Chlofazimine |
Clofazimine is an antimycobacterial drug. Clofazimine exerts a slow bactericidal effect on Mycobacterium leprae (Hansen’s bacillus). Clofazimine inhibits mycobacterial growth and binds preferentially to mycobacterial DNA. |
| List of Excipients |
|---|
|
Capsule content: Butylated hydroxytoluene Capsule shell: Ethyl parahydroxybenzoate sodium |
LAMPRENE 50/100 mg soft gelatin capsules are either packaged in white to off-white high density polyethylene (HDPE) bottles with a HDPE screw cap with a yellow tamper proof ring, further packaged in paper board carton or can be packaged in low density polyethylene (LDPE) bags inserted in high density polyethylene (HDPE) bottle with a HDPE screw cap.
Kindly note that not all strengths may be marketed.
Novartis South Africa (Pty) Ltd, Magwa Crescent West, Jukskei View, Waterfall City, Johannesburg, 2090
LAMPRENE 50 mg soft gelatin capsules: 53/20.2.4/0472
LAMPRENE 100 mg soft gelatin capsules: B/20.2.4/108
19 April 2018
| Drug | Countries | |
|---|---|---|
| LAMPRENE | Estonia, France, Malta, South Africa |
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