Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660
ORATANE 5 mg soft gelatin capsule.
ORATANE 10 mg soft gelatin capsule.
ORATANE 20 mg soft gelatin capsule.
ORATANE 30 mg soft gelatin capsule.
ORATANE 40 mg soft gelatin capsule.
| Pharmaceutical Form |
|---|
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ORATANE 5 mg capsules: Soft gelatin oval opaque white capsules, approximately 8 mm in length and 5 mm in diameter. ORATANE 10 mg capsules: Soft gelatin oval opaque violet capsules, approximately 10 mm in length and 7 mm in diameter. ORATANE 20 mg capsules: Soft gelatin oval opaque maroon capsules, approximately 13 mm in length and 8 mm in diameter. ORATANE 30 mg capsules: Soft gelatin oval opaque pink capsules, approximately 12 mm length and 8 mm in diameter. ORATANE 40 mg capsules: Soft gelatin oval opaque light orange capsules, approximately 13 mm length and 8 mm in diameter. |
Each ORATANE 5 mg soft gelatin capsule contains 5 mg of isotretinoin.
Each ORATANE 10 mg soft gelatin capsule contains 10 mg of isotretinoin.
Each ORATANE 20 mg soft gelatin capsule contains 20 mg of isotretinoin.
Each ORATANE 30 mg soft gelatin capsule contains 30 mg of isotretinoin.
Each ORATANE 40 mg soft gelatin capsule contains 40 mg of isotretinoin.
Excipient(s) with known effect: ORATANE soft gelatin capsules contain soyabean products. Sulfur dioxide is present as a residue in gelatin.
For the full list of excipients, see Section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Isotretinoin |
Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin has been established. |
| List of Excipients |
|---|
|
ORATANE 5 mg soft gelatin capsules contains the following excipients: Butylated hydroxyanisole, disodium edetate, dl-Alpha tocopherol, gelatin, glycerol, hydrogenated vegetable oil, purified water, sorbitol, soya oil, titanium dioxide, and yellow beeswax. ORATANE 10 mg soft gelatin capsule contains the following excipients: Butylated hydroxyanisole, disodium edetate dihydrate, dl-Alpha tocopherol, gelatin, glycerol, hydrogenated vegetable oil, iron oxide black, ponceau 4R, purified water, sorbitol, soya oil, titanium dioxide, and yellow beeswax. ORATANE 20 mg soft gelatin capsule contains the following excipients: Butylated hydroxyanisole, disodium edetate dihydrate, dl-Alpha tocopherol, gelatin, glycerol, hydrogenated vegetable oil, indigo carmine, ponceau 4R, purified water, sorbitol, soya oil, titanium dioxide, and yellow beeswax. ORATANE 30 mg soft gelatin capsule contains the following excipients: Butylated hydroxyanisole, disodium edetate dihydrate, dl-Alpha tocopherol, gelatin, glycerol, iron oxide red, sorbitol, hydrogenated soya bean oil, soya oil, titanium dioxide, and yellow beeswax. ORATANE 40 mg soft gelatin capsule contains the following excipients: Butylated hydroxyanisole, disodium edetate dihydrate, all-rac-alpha-tocopherol, gelatin, glycerol, purified water, sorbitol, hydrogenated soya bean oil, soya oil, sunset yellow FCF, titanium dioxide, and yellow beeswax. |
ORATANE 5 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 60 capsules.
ORATANE 10 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 15 capsules as a starter pack, 60, 120 or 180 capsules.
ORATANE 20 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 15 capsules as a starter pack, 60, 90, 120 or 180 capsules.
ORATANE 30 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 60 or 120 capsules.
ORATANE 40 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 30 capsules.
Not all strengths or pack sizes may be marketed.
Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660
ORATANE 5 mg soft gelatin capsules: 06 August 2009
ORATANE 10 mg soft gelatin capsules: 24 May 2001
ORATANE 20 mg soft gelatin capsules: 20 May 1999
ORATANE 30 mg soft gelatin capsules: 26 July 2012
ORATANE 40 mg soft gelatin capsules: 13 July 2006
| Drug | Countries | |
|---|---|---|
| ORATANE | Australia, Hong Kong, New Zealand, Singapore, South Africa |
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