THE LONDON GAZETTE, 27TH MARCH 1997                                                                                    3785
Product Licence            Company                        Product                             Active                                 Indications                     Date of
    Number                  Name                           Name                             Ingredients                                                            Authorisation
12063/0023        Wrafton Laboratories          Junior Expectorant Cough      Guaiphenesin 100 000 mg                    To loosen stubborn mucus and            7th March 1997
                  Limited                       Syrup                                                                    clear chesty coughs.
                                                                                                                         General Sales List
12063/0024        Wrafton Laboratories          Dry Cough Syrup               Dextromethorphan Hydrobromide              To soothe and control dry coughs.       7th March 1997
                  Limited                                                     1 5-000 mg                                 Pharmacy Medicine
12063/0025        Wrafton Laboratories          Dry Cough Syrup with          Dextromethorphan Hydrobromide              To soothe and control dry coughs.       7th March 1997
                  Limited                       Decongestant                  20 000 me                                  Also effective in the relief of nasal
                                                                              Pseudoephedrine Hydrochloride              congestion, catarrh and blocked
                                                                              60-000 mg                                  sinus.
                                                                                                                         Pharmacy Medicine
12724/0200        Regent-GM Laboratories        Ibuprofen Tablets BP 200 mg   Iburprofen 200-0 mg                        Prescription Only Medicine:             10th March
                  Limited                                                                                                Ibuprofen is indicated in the           1997
                                                                                                                         treatment of rheumatoid arthritis
                                                                                                                         (including juvenile rheumatoid
                                                                                                                         arthritis) ankylosing spondylitis,
                                                                                                                         osteoarthritis, other non-
                                                                                                                         rheumatoid (seronegative)
                                                                                                                         arthropathies, periarticular
                                                                                                                         conditions such as frozen shoulder,
                                                                                                                         bursitis, tendinitis, etc., low back
                                                                                                                         pain, sprains, strains,
                                                                                                                         dysmenorrhoea, dental and post
                                                                                                                         operative pain and migraine.
                                                                                                                         Pharmacy medicine: The legal
                                                                                                                         category for Ibuprofen tablets BP
                                                                                                                         200 mg up to a pack size of 36
                                                                                                                         tablets is "pharmacy" medicine.
                                                                                                                         The indications applicable to the
                                                                                                                         "pharmacy" product are as
                                                                                                                         follows: For the relief of rheumatic
                                                                                                                         and muscular pain, backache,
                                                                                                                         neuralgia, migraine, headache,
                                                                                                                         colds and flu, fever, dental and
                                                                                                                         period pain.
12724/0201        Regent-GM Laboratories         Ibruprofen Tablets BP 400 mg Ibruprofen 400-0 mg                        Ibuprofen is indicated in the           IOth March
                  Limited                                                                                                treatment of rheumatoid arthritis,      1997
                                                                                                                         ankylosing spondylitis
                                                                                                                         osteoarthritis, non-articular
                                                                                                                         rheumatism, soft-tissue injuries
                                                                                                                         and conditions such as frozen
                                                                                                                         shoulder, seronegative (non-
                                                                                                                         rheumatoid) arthropathies,
                                                                                                                         bursitis, tenosynovitis. Its
                                                                                                                         analgesic activity is of benefit in
                                                                                                                         treating dental and post operative
                                                                                                                         pain, dysmenorrhoea, headaches,
                                                                                                                         rheumatic and muscular pain,
                                                                                                                         backache, sprains, lumbago and
                                                                                                                         Prescription Only Medicine
13042/0001        Pharmadass Limited             Nasciodine Massage Cream     Iodine EP 1-26 w/w, Racementhol EP         For the symptomatic relief of           4th December
                                                                              0-59 w/w, Methyl Salicylate EP 3-87 w/w.   rheumatic pain, lumbago and             1996
                                                                              Turpentine Oil BP 3-87 w/w, Rectified      related back pain, sciatica,
                                                                              Camphor Oil (1959) BPC 3 87 w/w            fibrositis. muscular sprains and
                                                                                                                         strains, bruises, contusion,
                                                                                                                         chilblains and bunions.
                                                                                                                         General Sale List
13569/0001        Westminster Pharmaceuticals   Diaclear                      Loperamide Hydrochloride 2-0 mg            Symptomatic treatment of acute          10th December
                  Limited                                                                                                diarrhoea of any aetiology.             1996
                                                                                                                         Symptomatic treatment of acute
                                                                                                                         exacerbations of chronic diarrhoea
                                                                                                                         for treatments of up to 5 days, in
                                                                                                                         adults and children over 9 years.
                                                                                                                         Symptomatic treatment of chronic
                                                                                                                         diarrhoea in adults.
                                                                                                                         Prescription Only Medicine
13606/0010        Co-Pharma Limited             Cloxacillin Capsules          Cloxacillin 250-0 mg                       Treatment of infections due to          llth March
                                                BP250mg                                                                  gram-positive organisms including       1997
                                                                                                                         beta-lactamase producing
                                                                                                                         staphylococci. Such indications
                                                                                                                         include: Respiratory tract
                                                                                                                         infections such as pneumonia,
                                                                                                                         pharyngitis, tonsillitis, lung
                                                                                                                         abscess, sinusitis, quinsy. Skin and
                                                                                                                         soft tissue infections such as boils,
                                                                                                                         abscesses, carbuncles, skin ulcers,
                                                                                                                         eczema and acne, furunculosis.
                                                                                                                         cellulitis, infected wounds and
                                                                                                                         burns, skin-graft protection, otitis
                                                                                                                         media and externa. Infections due
                                                                                                                         to cloxacillin-sensitive organisms
                                                                                                                         such as enteritis endocarditis,
                                                                                                                         meningitis, osteomyelitis,
                                                                                                                         septicaemia and urinary tract
                                                                                                                         infections. Prophylaxis during
                                                                                                                         major surgery where appropriate
                                                                                                                         e.g. cardiothoracic and
                                                                                                                         orthopaedic surgery.
                                                                                                                         Prescription Only Medicine
13606/0011        Co-Pharma Limited             Cloxacillin Capsules          Cloxacillin 500-0 mg                       (See PL/13606/0010.)                    llth March
                                                BP 500 mg                                                                Prescription Only Medicine              1997
13826/0027        Caseview PL Limited           ISO Mono 60 mg Tablets        Isosorbide Mononitrate 60-0 mg             Prophylactic treatment of angina        3rd March 1997
                                                                                                                         Prescription Only Medicine
13826/0050        Caseview PL Limited           Serevent Inhaler              Salmeterol Xinafoate 36-300 mg             Treatment of reversible airways         14th March
                                                                                                                         obstructions.                           1997
                                                                                                                         Prescription Only Medicine
13826/0053        Caseview PL Limited           Voltaren Retard Tablets       Diclofenac Sodium 100-Omg                  Relief of all grades of pain and        21st February
                                                100 mg                                                                   inflammation in arthritic               1997
                                                                                                                         conditions and other painful
                                                                                                                         conditions resulting from trauma.
                                                                                                                         Prescription Only Medicine
13826/0054        Caseview PL Limited           Prepulskt 10 mg Tablets       Cisapride 10-Omg                           Treatment of symptoms associated        5th March 1997
                                                                                                                         with gastro-oesophageal reflux.

To top