Generic name |
clostridium botulinum neurotoxin type A, with complexing proteins, also known as onabotulinumtoxinA |
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Strength |
50 units/vial, 100 units/vial, 200 units/vial |
Form |
concentrate powder for solution for injection |
Special Authority criteria |
Approval period |
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Initial: 1 year Renewali: 3 years |
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Initial: 1 year Renewali: 3 years |
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Initial: 1 year Renewali: 3 years |
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Initial: 1 year Renewali: 3 years |
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Initial: 1 year Renewali: 3 years |
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Initial: 1 course (maximum 200 units) Renewalii: 1 year (coverage is provided for treatment with up to 200 units per course at minimum intervals of 36 weeks) |
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Initial: 1 course (maximum 100 units) Renewalii: 1 course (coverage is provided for treatment with up to 100 units per course at minimum intervals of 12 weeks, to a maximum of 3 courses per year) |