Product specific guidance EMA [BE/BA News]
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]
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]
Complete thread:
- Product specific guidance EMAMahesh M 2015-10-07 09:51
- Product specific guidance EMA Helmut 2016-05-03 00:29