Product specific guidance EMA [BE/BA News]

posted by Mahesh M – India, 2015-10-07 11:51 (3505 d 19:54 ago) – Posting: # 15523
Views: 7,827

Dear All,

EMA release Product specific guidance for below product

Scientific guideline: Draft ticagrelor film-coated tablets 90mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft entecavir film-coated tablets 0.5 and 1 mg, oral solution 0.05mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft entecavir film-coated tablets 0.5 and 1 mg, oral solution 0.05mg/ml product-specific bioequivalence guidance, draft: consultation open

Regards
M

Edit: Category changed. All product-specific guidances published so far: List. [Helmut]

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