CRED SMPC 2024

18/09/2024

Solution – Section 1

1. NAME OF THE MEDICINAL PRODUCT https://www.ema.europa.eu/en/documents/template-form/qrd-product information-annotated-template-english-version-104_en.pdf

TOPRAMAAX 10mg film-coated tablets TOPRAMAAX TOPRAMAAX 50mg film-coated TOPRAMAAX tablets TOPRAMAAX 100mg film-coated tablets

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Solution – Section 2

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

10 mgTOPRAMAAX 10mg film-coated tablets TOPRAMAAX Each tablet contains 10mg of toprexate Excipient with known effect 5.5mg lactose (as monohydrate) per tablet

50mg TOPRAMAAX 50mg film-coated tablets Each tablet contains 50mg of toprexate Excipient with known effect 10.3mg lactose (as monohydrate) per tablet

100 mgTOPRAMAAX 100mg film-coated tablets TOPRAMAAX Each tablet contains 100mg of toprexate Excipient with known effect 20.5mg lactose (as monohydrate) per tablet

For the full list of excipients, see section 6.1

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