Tibolone 2.5mg Tablets
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1. Trade Name of the Medicinal Product Not applicable
2. Qualitative and Quantitative Composition
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3. Pharmaceutical Form
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Clinical Particulars
4.1. Therap euti c Indi cati ons Not applicable
4.2. Posology and Method of Administration
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4.3. Contra-indications
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4.4. Special Warnings and Precautions for Use
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4.5. Interactions with other Medicaments and other forms of Interaction
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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Pharmacological Properties
5.1. Pharmacodynamic Properties Not applicable
5.2. Pharmacokinetic Properties
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5.3. Preclinical Safety Data
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Pharmaceutical Particulars
6.1. List of Excipients Not applicable
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/Handling
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Administrative Data
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8. Marketing Authorization Number
Date of First Authorisation/Renewal of Authorisation
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Date of (Partial) Revision of the Text
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