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SMC ID Date Medicine Submission Type Indication
SMC2904 12/10/2026 betula verrucosa (Itulazax) Full

In adults and children (5 years or older) for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group. It is indicated in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE).
SMC2885 10/08/2026 D. pteronyssinus & D. farinae allergen extracts (Acarizax) Full

Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions:

  • persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication
  • house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment

 
SMC2651 08/07/2024 birch bark extract (Filsuvez) Ultra-orphan initial assessment

For treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged 6 months and older.
SMC2613 07/08/2023 Dermatophagoides pteronyssinus and Dermatophagoides farinae (Acarizax) Non submission

Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions:
• persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication
• house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment
SMC2453 11/07/2022 delafloxacin (Quofenix) Full

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections.
SMC2285 09/05/2022 oritavancin (Tenkasi) Resubmission

For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
SMC2471 07/03/2022 betula verrucosa (Itulazax) Non submission

In adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group.
1309/18 12/02/2018 daptomycin (Cubicin) Non submission

Treatment of paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia associated with complicated skin and soft-tissue infections.
1306/18 15/01/2018 ceftaroline fosamil (Zinforo) Non submission

treatment of complicated skin and soft tissue infections in children from the age of 2 months • community-acquired pneumonia in children from the age of 2 months
1287/17 13/11/2017 abatacept (Orencia) Non submission Alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.
1105/15 16/01/2017 dalbavancin (Xydalba) Full Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
1141/16 07/03/2016 daptomycin (Cubicin) Non submission

Treatment of paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections.
1101/15 07/09/2015 tigecycline (Tygacil) Non submission

Treatment in children from the age of eight years for the following infections: complicated skin and soft tissue infections, excluding diabetic foot infections complicated intra-abdominal infections
1080/15 10/08/2015 tedizolid phosphate (Sivextro) Full The treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
1000/14 13/10/2014 tetracaine idocaine (Pliaglis) Non submission Local dermal anaesthesia on intact skin prior to dermatological procedures in adults
882/13 10/06/2013 canakinumab (Ilaris) Non submission Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above
868/13 08/04/2013 timothy grass pollen allergen (GRAZAX) Non submission Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children (5 years or older), with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.
830/12 14/01/2013 ceftaroline fosamil (Zinforo) Full For the treatment of complicated skin and soft tissue infections (cSSTIs).
650/10 13/12/2010 moxifloxacin (Avelox IV) Full Community Acquired Pneumonia (CAP)
622/10 09/08/2010 betamethasone valerate 2.25mg medicated plaster (Betesil) Full Inflammatory skin disorders which do not respond to treatment with less potent corticosteroids.
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