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Cefixime 400 mg Film-coated Tablets, PL 22805 …

MHRA PAR; Cefixime 400 MG Film-coated TABLETS, PL 22805 /0032-3 1 Public Assessment Report Decentralised Procedure Cefixime 400 mg Film-coated Tablets PL 22805 /0032 PL 22805 /0033 UK/H/1532/001/DC UK/H/3965/001/DC Orchid Europe Ltd. MHRA PAR; Cefixime 400 MG Film-coated TABLETS, PL 22805 /0032-3 2 Lay summary The Medicines and Healthcare products Regulatory Agency (MHRA) granted Orchid Europe Ltd. Marketing Authorisations (licences) for the medicinal product Cefixime 400 mg Film-coated Tablets (product licence numbers: PL 22805 /0032 and PL 22805 /0033) on 16 December 2010. This medicine is available on prescription only. Cefixime belongs to a group of medicines called cephalosporins, which are used for treating infections. Cefixime 400 mg Film-coated Tablets are used to treat: Infection of the middle ear Sinus infection Throat infection Infection causing sudden worsening of long-standing bronchitis Lung infections (pneumonia) acquired outside hospital Infections in the urinary tract including some infections of the kidneys The data submitted in support of these applications for Cefixime 400 mg Film-coated Tablets raised no clinically significant safety concerns and it was, therefore, judged that the benefits of using this product outweigh the risks; hence Marketing Authorisations have been granted.

MHRA PAR; CEFIXIME 400 MG FILM-COATED TABLETS, PL 22805/0032-3 2 Lay summary The Medicines and Healthcare products Regulatory Agency …

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