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RegisterMesalazine tablets for Europe Market [RSABE / ABEL]
Dear All,
Please provide the valuable suggestion for below mentioned product for Europe submission,
1) We would like to know what kind of studies required for Mesalazine Gastro-resistant MR tablets for Europe Market.
2) Do we need to conduct the studies on 400 mg & 800 mg or any one of the strengths? At what dose the study should be conducted.
3) Please also propose the approx. number of subjects required for your proposed studies.
Regards
Kotu.
Edit: Category changed. [Helmut]
Please provide the valuable suggestion for below mentioned product for Europe submission,
1) We would like to know what kind of studies required for Mesalazine Gastro-resistant MR tablets for Europe Market.
2) Do we need to conduct the studies on 400 mg & 800 mg or any one of the strengths? At what dose the study should be conducted.
3) Please also propose the approx. number of subjects required for your proposed studies.
Regards
Kotu.
Edit: Category changed. [Helmut]
Complete thread:
- Mesalazine tablets for Europe Marketbalakotu 2015-10-19 09:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Mesalazine tablets for Europe Market komodo 2015-10-23 08:52
- Generic of an extremely HVDP possible? Helmut 2015-10-23 13:09
- Generic of an extremely HVDP possible? nobody 2015-10-23 14:46
- Generic of an extremely HVDP possible? Helmut 2015-10-23 13:09
- Mesalazine tablets for Europe Market komodo 2015-10-23 08:52
Ing. Helmut Schütz