|
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.
|
|
|
611/10
|
05/03/2010
|
omalizumab (Xolair)
|
Abbreviated
|
For children between 6 and less than 12 years of age with severe persistent allergic asthma.
|
|
