Bioequivalence and Bioavailability Forum • Product specific guidance EMA

Mahesh M
★

India,
2015-10-07 11:51
(3905 d 22:23 ago)

Posting: # 15523
Views: 9,262

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
★★★

Vienna, Austria,
2016-05-03 02:29
(3697 d 07:44 ago)

@ Mahesh M
Posting: # 16262
Views: 6,358

Product specific guidance EMA

Post reply

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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