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RegisterEMA: New product-specific draft guidances published [BE/BA News]
Dear All,
EMA published new product specific draft guidances for public consultation.
Regards,
MMW
Edit: Links added; end of consultation 30 September 2018. [Helmut]
EMA published new product specific draft guidances for public consultation.
- Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance
- Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance
- Draft lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
- Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance
- Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance
Regards,
MMW
Edit: Links added; end of consultation 30 September 2018. [Helmut]
Complete thread:
- EMA: 2 product-specific guidances adopted Helmut 2018-06-26 14:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: New product-specific draft guidances publishedmmw 2018-06-29 07:20
- EMA: New product-specific draft guidance published Helmut 2018-07-05 15:11
- EMA: 5 product-specific guidances adopted Helmut 2018-08-03 16:52
- EMA: New product-specific draft guidances publishedmmw 2018-06-29 07:20
Ing. Helmut Schütz