Con 041402

Paracetamol drug dosis
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  MHRA PAR; PARACETAMOL 500MG TABLETS, PL 21880/0014-6 1    Paracetamol 500mg Tablets PL 21880/0014-6 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of product characteristics Page 11 Product information leaflet Page 23 Labelling Page 35  MHRA PAR; PARACETAMOL 500MG TABLETS, PL 21880/0014-6 2  PARACETAMOL 500MG TABLETS PL 21880/0014-6 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency (MHRA) granted Medreich PLC Marketing Authorisations (licences) for the medicinal product Paracetamol 500mg Tablets (product licence numbers: 21880/0014-6). Paracetamol 500mg Tablets are used for the relief of mild to moderate pain, including headache, migraine, tension headaches, neuralgia, backache, toothache, sore throat, period pain, symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains,  joint swelling and stiffness, influenza, feverishness and feverish colds. They may also be used for symptomatic relief of pain due to non-serious arthritis.  No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking Paracetamol 500mg Tablets outweigh the risks, hence Marketing Authorisations have been granted.  MHRA PAR; PARACETAMOL 500MG TABLETS, PL 21880/0014-6 3  PARACETAMOL 500MG TABLETS PL 21880/0014-6 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Preclinical assessment Page 7 Clinical assessment (including statistical assessment) Page 8 Overall conclusions and risk benefit assessment Page 9  MHRA PAR; PARACETAMOL 500MG TABLETS, PL 21880/0014-6 4 INTRODUCTION Based on the review of the data on quality, safety and efficacy the UK granted marketing authorisations for the medicinal product Paracetamol 500mg Tablets (PL 21880/0014-6) on 4 February 2009. These medicinal products are identical but PL 21880/0014 is only available on  prescription, PL 21880/0015 is only available from pharmacies but can be bought without  prescription and PL 21880/0016 can be bought from pharmacies and other outlets without  prescription. Paracetamol is a mild analgesic and antipyretic. The tablets are recommended for headaches, including migraine and tension headaches, backache, rheumatic and muscle pain, period pains, nerve pains, toothache and for relieving the fever, aches and pains of colds and flu. These national complex abridged applications were made under Article 10a of Directive 2001/83/EC, known as bibliographic applications. The indications listed above are well known and therefore assigning these as bibliographical application is acceptable.


Jul 23, 2017
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