Transcription of Public Assessment Report Mutual Recognition …
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Public Assessment Report Mutual Recognition …
PAR diclofenac sodium 4% Spray Gel UK/H/0562-3/001/E01 1 Public Assessment Report Mutual Recognition Procedure diclofenac sodium 4% Spray Gel UK/H/0562-3/001/E01 Mika Pharma GmbH PAR diclofenac sodium 4% Spray Gel UK/H/0562-3/001/E01 2 diclofenac sodium 4% Spray Gel LAY SUMMARY Czech Republic, Poland, Slovak Republic, Estonia, Hungary, Latvia, Lithuania, Slovenia today granted Mika Pharma GmbH Marketing Authorisations (licences) for the medicinal products diclofenac sodium 4% Spray Gel (PL 18017/0001-2). These are prescription only medicines (POM) for the relief of acute pain and swelling affecting small or medium-sized joints and surrounding tissues. diclofenac sodium 4% Spray Gel contain the active ingredient diclofenac sodium , which belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAID). No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking diclofenac sodium 4% Spray Gel outweigh the risks, hence Marketing Authorisations have been granted.
PAR Diclofenac Sodium 4% Spray Gel UK/H/0562-3/001/E01 1 Public Assessment Report Mutual Recognition Procedure Diclofenac Sodium 4% Spray Gel
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