SUMMARY OF PRODUCT CHARACTERISTICS

Product Summary

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

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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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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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