Mahesh M
★    

India,
2015-10-07 11:51
(3095 d 14:04 ago)

Posting: # 15523
Views: 6,856
 

 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]
Helmut
★★★
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Homepage
Vienna, Austria,
2016-05-03 02:29
(2886 d 23:25 ago)

@ Mahesh M
Posting: # 16262
Views: 4,521
 

 Product specific guidance EMA

Dear All,

the EMA published another set of draft product-specific bioequivalence guidance.
  • Everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg
  • Fingolimod capsules 0.5mg
  • Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg
  • Paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg
  • Pazopanib film-coated tablet 200mg and 400mg
Consultation ends 31 Jul 2016.

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