EMA Product Specific GL [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-07-28 14:40 (2520 d 23:34 ago) – Posting: # 17620
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Dear all,

a new set of product-specific guidances was adopted by CHMP for public consultation on 22 June (published on 28 July [1–4], 3 August [5–7]). Deadline for comments: 31 October.
  1. Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg
  2. Dronedarone film-coated tablets 400 mg
  3. Paracetamol oral use, immediate release formulations
  4. Rilpivirine film-coated tablets 25 mg
  5. Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg
  6. Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg
  7. Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg

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