Selection of innovator product [Regulatives / Guidelines]

posted by pravin17 – India, 2010-12-13 10:26 (5675 d 06:06 ago) – Posting: # 6293
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(edited on 2010-12-13 13:24)

Dear Kishor,

For south africa submission you use MAXIPIME 2 g INJECTION as reference product (this is for cefepime).
and for Amikacin sulfate you take AMIKIN injection 500 mg as inovator.

Pravin Borde



Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]

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