Transcription of Public Assessment Report Repeat-Use Mutual …
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Public Assessment Report Repeat-Use Mutual …
PAR SolarazeTM 3% Gel UK/H/0226/001/E022. Public Assessment Report Repeat-Use Mutual recognition Procedure SolarazeTM 3% Gel UK/H/0226/002/E02. UK licence no: PL 16973/0012. Almirall, 1. PAR SolarazeTM 3% Gel UK/H/0226/001/E022. LAY SUMMARY. This Repeat-Use Mutual recognition Procedure (UK/H/0226/001/E02) granted a Marketing Authorisation to Almirall SA for the medicinal product Solaraze 3% Gel (PL 16973/0012) in Greece, Spain and Poland; the procedure concluded positively on 18th November 2010. A. national licence for Solaraze 3% Gel was initially granted in the UK on 25th July 1997. Solaraze is a non-steroidal anti-inflammatory gel that is applied to the skin. Solaraze gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure. Solaraze contains the active ingredient diclofenac sodium, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and act by reducing fever, and inflammation as well as the ability to reduce pain.
PAR SolarazeTM 3% Gel UK/H/0226/001/E022 1 Public Assessment Report Repeat-Use Mutual Recognition Procedure SolarazeTM 3% Gel UK/H/0226/002/E02 UK licence no: PL 16973/0012
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