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RegisterMontelukast sodium [Regulatives / Guidelines]
Dear JPL,
Yes I mean a similar drug to Singulair granules 4 mg that is marketed for children.
The application will be similar.
the question was if we have done a bioequivalence study in adults, comparing tabelts, will it be sufficient to support the launching of a 4 mg granules in sachets, or will the authorities ask us to perform a bioequivalence study with the reference as granules as well
Thanks
--
Edit: Full quote removed. Please see this post! [Ohlbe]
Yes I mean a similar drug to Singulair granules 4 mg that is marketed for children.
The application will be similar.
the question was if we have done a bioequivalence study in adults, comparing tabelts, will it be sufficient to support the launching of a 4 mg granules in sachets, or will the authorities ask us to perform a bioequivalence study with the reference as granules as well
Thanks
--
Edit: Full quote removed. Please see this post! [Ohlbe]
Complete thread:
- monelukast sodium talr 2008-11-09 16:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- monelukast sodium JPL 2008-11-10 09:58
- Montelukast sodiumtalr 2008-11-10 10:16
- Montelukast sodium JPL 2008-11-13 15:02
- Montelukast sodium Ohlbe 2008-11-13 15:42
- Montelukast sodium talr 2008-11-15 12:54
- Montelukast sodium Ohlbe 2008-11-13 15:42
- Montelukast sodium JPL 2008-11-13 15:02
- Montelukast sodiumtalr 2008-11-10 10:16
- monelukast sodium JPL 2008-11-10 09:58
Ing. Helmut Schütz