Product specific guidance EMA [BE/BA News]
Dear All,
the EMA published another set of draft product-specific bioequivalence guidance.
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
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Product specific guidance EMA Mahesh M 2015-10-07 09:51
- Product specific guidance EMAHelmut 2016-05-03 00:29