Summary of Product Characteristics (SmPC) - Modafinil 100 mg tablets, Provigil 100 mg tablets
1. NAME OF THE MEDICINAL PRODUCT
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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
Not applicable
4.6. Pregnancy and lactation
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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
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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
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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
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8. Marketing Authorisation Number
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9. Date of First Authorisation/Renewal of Authorisation
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10. Date of (Partial) Revision of Text
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