Transcription of Public Assessment Report Decentralised Procedure - GOV.UK
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Public Assessment Report Decentralised Procedure - GOV.UK
Public Assessment Report Decentralised Procedure CLOBAVATE W/W OINTMENT (Clobetasone butyrate) Procedure No: UK/H/3212/001/DC UK Licence No: PL 17507/0118 AUDEN MCKENZIE (PHARMA DIVISION) LTD PAR Clobavate w/w Ointment UK/H/3212/001/DC 2 LAY SUMMARY On 17 December 2012, Ireland and the UK agreed to grant a Marketing Authorisation to Auden Mckenzie (Pharma Division) Ltd for the medicinal product Clobavate w/w Ointment (PL 17507/0118; UK/H/3212/001/DC). The licence was granted via the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS). After a subsequent national phase, a Marketing Authorisation was granted in the UK on 18 January 2013. This is a prescription-only medicine (POM). Clobavate w/w Ointment contains the active ingredient clobetasone butyrate which belongs to a group of medicines called steroids.
PAR Clobavate 0.05% w/w Ointment UK/H/3212/001/DC 2 LAY SUMMARY On 17 December 2012, Ireland and the UK agreed to grant a Marketing Authorisation to
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