Transcription of Public Assessment Report Decentralised Procedure …
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Public Assessment Report Decentralised Procedure …
PAR Propafenone hydrochloride 150mg and 300mg Film-coated Tablets PL 20620/0034-5; UK/H/1208/01-02/DC 1 Public Assessment Report Decentralised Procedure Propafenone hydrochloride 150mg Film-coated Tablets Propafenone hydrochloride 300mg Film-coated Tablets (propafenone hydrochloride) UK/H/1208/01-02/DC UK licence numbers: PL 20620/0034-5 NRIM Limited PAR Propafenone hydrochloride 150mg and 300mg Film-coated Tablets PL 20620/0034-5; UK/H/1208/01-02/DC 2 LAY SUMMARY On 24th December 2010, the MHRA granted NRIM Limited Marketing Authorisations (licences) for the medicinal products Propafenone hydrochloride 150mg Film-coated Tablets and Propafenone hydrochloride 300mg Film-coated Tablets (PL 20620/0034-5). These are prescription-only medicines (POM). Propafenone is one of a group of medicines called anti-arrhythmic agents and is used for the following: To slow down the heart rate and help to regulate the heartbeat To treat and prevent arrhythmias (abnormal heart rhythms) The test products were considered to be generic versions of the reference products Arythmol 150mg and 300mg tablets (PL 00037/0331 and 0332, Abbott Laboratories Limited) based on the data submitted by NRIM Limited.
PAR Propafenone hydrochloride 150mg and 300mg Film-coated Tablets PL 20620/0034-5; UK/H/1208/01-02/DC 1 Public Assessment Report Decentralised Procedure
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