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New EMA product specific guidance (PSG) [BE/BA News]

posted by SMA – Europe, 2024-01-16 10:51 (541 d 18:13 ago) – Posting: # 23828
Views: 3,790
(edited on 2024-01-16 11:07)

Dear all

EMA has published two new PSGs:

Azacitidine powder for suspension for injection 25 mg/ml product-specific bioequivalence guidance (here)
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance (here)

Consultations open until 2024-04-30

Complete thread:

New EMA product specific guidance (PSG)SMA 2024-01-16 09:51 [BE/BA News]
- New EMA product specific guidance (PSG) dshah 2024-01-17 10:12

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