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Page: Ledipasvir/sofosbuvir product-specific bioequivalence guidance-2025/7/10
2025-07-11查看详情 > -
Document: Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1-2025/7/10
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Document: Guide to CTIS training material catalogue-2025/7/9
2025-07-10查看详情 > -
Document: Clinical Trial Information System (CTIS) structured data form -– Notifications, Annual Safety Report (ASR) and results-2025/7/9
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Document: Minutes of the HMPC meeting 5-7 May 2025-2025/7/9
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Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)-2025/7/9
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Document: Clinical Trial Information System (CTIS) - Sponsor handbook-2025/7/9
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Document: Minutes - PDCO minutes of the 20-23 May 2025 meeting-2025/7/8
2025-07-09查看详情 > -
Document: Dates of 2026 Scientific Advice Working Party (SAWP) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests-2025/7/8
2025-07-09查看详情 > -
Document: Minutes of the CHMP meeting 24-27 February 2025-2025/7/8
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