PENTAMIDINE-EMC (Emcure Pharmaceuticals Pty Ltd)

Product name

PENTAMIDINE-EMC

Date registered

26 September 2023

Evaluation commenced

31 July 2020

Decision date

31 August 2023

Approval time

149 (255 working days

Active ingredients

Pentamidine isetionate

Registration type

New generic medicine

Indication

Pentamidine isethionate is indicated for intravenous administration in the treatment of the following conditions:

As an alternative first line treatment for Pneumocystis carinii infection in AIDS patients;
As second line treatment for Pneumocystis carinii infection in non-AIDS patients;
As second line treatment of Leishmaniasis (visceral and cutaneous), except Leishmania aethiopica where it may be used as first line therapy;
As second line treatment for Trypanosomiasis (except for the Trypanosomiasis rhodesiense strain due to lack of efficacy).

Registration process

First generic

First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine