Transcription of Public Assessment Report Decentralised Procedure …
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Public Assessment Report Decentralised Procedure …
Public Assessment Report Decentralised Procedure CANDESARTAN CILEXETIL 4 MG TABLETS CANDESARTAN CILEXETIL 8 MG TABLETS CANDESARTAN CILEXETIL 16 MG TABLETS CANDESARTAN CILEXETIL 32 MG TABLETS (Candesartan cilexetil) Procedure No: UK/H/3012/001-4/DC UK Licence No: PL 18909/0355-8 ARROW GENERICS LIMITED PAR Candesartan cilexetil 4 mg, 8 mg, 16 mg and 32 mg Tablets UK/H/3012/001-4/DC LAY SUMMARY On 12 December 2011, Germany, Denmark, Finland, France, Poland, Spain, Sweden and the UK agreed to grant Marketing Authorisations to Arrow Generics Limited for the medicinal products Candesartan cilexetil 4 mg, 8 mg, 16 mg and 32 mg Tablets (PL 18909/0355-8; UK/H/3012/001-4/DC). The licences were granted via the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS). After a subsequent national phase, Marketing Authorisations were granted in the UK on 10 January 2012. These are Prescription-Only Medicines (POM). Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists.
Public Assessment Report Decentralised Procedure CANDESARTAN CILEXETIL 4 MG TABLETS CANDESARTAN CILEXETIL 8 MG TABLETS CANDESARTAN CILEXETIL 16 MG TABLETS
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