Transcription of Public Assessment Report Decentralised Procedure …
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Public Assessment Report Decentralised Procedure …
Public Assessment Report Decentralised Procedure METFORMIN HYDROCHLORIDE 500MG FILM-COATED TABLETS METFORMIN HYDROCHLORIDE 850MG FILM-COATED TABLETS METFORMIN HYDROCHLORIDE 1000mg FILM-COATED TABLETS Procedure No: UK/H/1962 and 2397/001-3/DC UK Licence No: PL 32870/0001-3 and 0014-6 USV Europe Limited PAR Metformin Hydrochloride 500, 850 and 1000mg Film-Coated Tablets UK/H/1962 and 2397/001-3/DC 2 LAY SUMMARY On 18th September 2009, the MHRA granted USV Europe Limited Marketing Authorisations (licences) for the medicinal products Metformin Hydrochloride 500, 850 and 1000mg Film-Coated Tablets (PL 32870/0001-3 and 0014-6). These are prescription-only medicines (POM) that are used for the treatment of non-insulin-dependent diabetes mellitus (type 2 diabetes) in adults and children from 10 years of age.
PAR Metformin Hydrochloride 500, 850 and 1000mg Film-Coated Tablets UK/H/1962 and 2397/001-3/DC 6 4.3 Contraindications • Hypersensitivity to metformin hydrochloride or to any of the excipients.
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