Product Summary

1.    Trade 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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Clinical Particulars

4.1.    Therapeutic Indications

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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

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4.6.    Pregnancy and Lactation

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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

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5.2.    Pharmacokinetic Properties

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5.3.    Preclinical Safety Data

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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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6.6.    Instruction for Use/Handling

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Administrative Data

7.    Marketing Authorisation Holder

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8.    Marketing Authorization Number

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9.    Date of First Authorisation/Renewal of Authorisation

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10.    Date of (Partial) Revision of the Text

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