Avodart 0.5mg Soft Capsules/Dutasteride 0.5mg Soft Capsules
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1. NAME OF THE MEDICINAL PRODUCT Not applicable
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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3. PHARMACEUTICAL FORM
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4. CLINICAL PARTICULARS
4.1. Therapeutic indications
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4.2. Posology and method of administration
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4.3. Contraindications
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4.4. Special warnings and precautions for use
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4.5. Interactions with other medicinal products and other forms of interaction
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Pregnancy and lactation
4.6.
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4.7. Effects on ability to drive and use machines
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4.8. Undesirable effects
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4.9. Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
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5.2. Pharmacokinetic properties
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5.3. Preclinical safety data
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6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
6.2. Incompatibilities
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6.3. Shelf life
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6.4. Special precautions for storage
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6.5. Nature and contents of container
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6.6. Instruction for use and handling (, and disposal)
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No Data Held Administrative Data
7. MARKETING AUTHORISATION HOLDER Not applicable
8. MARKETING AUTHORISATION NUMBER
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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
DATE OF REVISION OF THE TEXT
10.
Not applicable