Mesalazine tablets for Europe Market [RSABE / ABEL]

posted by balakotu – India, 2015-10-19 11:47 (3400 d 19:21 ago) – Posting: # 15570
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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]

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