Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Imnovid 1 mg hard capsules Each hard capsule contains 1 mg of pomalidomide. Imnovid 2 mg hard capsules Each hard capsule contains 2 mg of pomalidomide. Imnovid 3 mg hard capsules Each hard capsule contains 3 mg of pomalidomide. Imnovid 4 mg hard capsules Each hard capsule contains 4 mg of pomalidomide. For the full list of excipients, see section 3. PHARMACEUTICAL FORM Hard capsule Imnovid 1 mg hard capsules Dark blue opaque cap and yellow opaque body, imprinted POML in white ink and 1 mg in black ink, size 3 gelatin hard capsule.
Summary of Product Characteristics (SmPC). Table 6. Dexamethasone dose reduction Dose Level ≤ 75 years old Days 1, 8, 15 and 22 of each 28-day cycle > 75 years old Days 1, 8, 15 and 22 of each 28-day cycle Starting Dose 40 mg 20 mg Dose Level -1 20 mg 12 mg Dose Level …
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