Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. name OF THE MEDICINAL PRODUCT Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tecfidera 120 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate Tecfidera 240 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Tecfidera 120 mg gastro-resistant hard capsules Green and white gastro-resistant hard capsules, size 0, printed with BG-12 120 mg containing microtablets.
SUMMARY OF PRODUCT CHARACTERISTICS . 2 1. NAME OF THE MEDICINAL PRODUCT ... Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed. 3 ... 1. NAME OF THE MEDICINAL PRODUCT Tecfidera 120 mg gastro-resistant hard capsules . Tecfidera 120 mg .
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