EMA: New product-specific draft guidances published [BE/BA News]

posted by mmw – India, 2018-06-29 09:20 (2357 d 05:15 ago) – Posting: # 18993
Views: 5,529

Dear All,

EMA published new product specific draft guidances for public consultation.
  1. Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance
  2. Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance
  3. Draft lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
  4. Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance
  5. Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance

Regards,

MMW

Edit: Links added; end of consultation 30 September 2018. [Helmut]

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