NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
The work programme features only submissions that have been scheduled for assessment over the coming 2/3 months.
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| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| There are currently no submissions for this category. | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| bivaluridin (Angiox) | The Medicines Company | 13.09.10 | Full submission | 12.07.10 |
anticoagulant in adult patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. | ||||
| dronedarone (Multaq) | Sanofi-aventis Ltd | 13.09.10 | Full submission | 12.07.10 |
for the treatment of atrial fibrillation | ||||
| ranolazine (Ranexa) | A Menarini Pharma UK SRL | 13.12.10 | Resubmission | 11.10.10 |
Angina pectoris | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| agomelatine (Valdoxan) | Servier | 13.09.10 | Resubmission | 12.07.10 |
for the treatment of major depressive episodes in adults. | ||||
| aripiprazole (Abilify) | Bristol-Myers Squibb / Otsuka Pharmaceuticals | 13.09.10 | Abbreviated Submission | |
for the treatment of schizophrenia in adolescents | ||||
| capsaicin (Qutenza) | Astellas Pharma UK Ltd | tbc | Full submission | tbc |
peripheral neuropathic pain in non-diabetic adults | ||||
| diclofenac 4% gel spray (Mobigel) | Goldshield Pharmaceuticals Limited | tbc | Abbreviated Submission | tbc |
Local symptomatic relief of mild to moderate pain and inflammation | ||||
| eslicarbazepine (Zebinix) | Eisai Ltd. | 08.11.10 | Resubmission | 13.09.10 |
As adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation | ||||
| fentanyl pectin nasal spray (PecFent) | Archimedes Pharma | tbc | Full submission | tbc |
Breakthrough pain in chronic cancer pain | ||||
| levetiracetam (Keppra) | UCB Pharma | TBC | Abbreviated Submission | TBC |
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy | ||||
| oxycodone injection (Oxynorm) | Napp Pharmaceuticals Ltd | 08.11.10 | Full submission | 13.09.10 |
for the treatment of moderate to severe pain in patients with cancer. | ||||
| prilocaine (Prilotekal) | Goldshield Group | tbc | Full submission | tbc |
Spinal anaesthesia | ||||
| tapentadol hydrochloride (Palexia) | Grunenthal Ltd | 13.12.10 | Full submission | 11.10.10 |
Severe chronic pain | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| There are currently no submissions for this category. | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| denosumab (Prolia) | Amgen | 13.12.10 | Full submission | 11.10.10 |
Osteoporosis in postmenopausal women at increased risk of fractures and treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk fractures. | ||||
| denosumab (Prolia) | Amgen Uk & Ireland Ltd | 13.12.10 | Full submission | 11.10.10 |
Osteoporosis in postmenopausal women | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| dexamethasone (Ozurdex) | Allergan Ltd | 13.12.10 | Full submission | 11.10.10 |
Macular oedema | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| There are currently no submissions for this category. | ||||
| prucalopride (Prilotekal) | Movetis UK Regus | 13.12.10 | Full submission | 11.10.10 |
Chronic constipation in women | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| moxifloxacin (Avelox IV) | Bayer Schering | 13.12.10 | Full submission | 11.10.10 |
Community acquired pneumonia (CAP) | ||||
| moxifloxacin hydrochloride solution for infusion (Avelox IV) | Bayer Schering Ltd. | 13.12.10 | Full submission | 11.10.10 |
For the treatment of community acquired infection (CAP) | ||||
| valganciclovir (Valcyte) | Roche | tbc | Full submission | tbc |
Prevention of cetomegalovirus (CMV) disease in CMV-negative patients who have received a solid organ transplant from CMV-positive donor | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| abarelix (Plenaxis) | Speciality European Pharma (SEP | tbc | Full submission | |
Hormonal castration in patients with advanced or metastatic hormone-dependent prostate cancer, if androgen suppression is appropriate | ||||
| buserelin acetate (Suprefact Depot) | Sanofi-Aventis | tbc | Full submission | |
Advanced hormone-dependant prostatic carcinoma | ||||
| docetaxel (Taxotere) | Sanofi-Aventis | tbc | Abbreviated Submission | tbc |
1-vial Taxotere has been developed to offer a simplified one-step and time saving preparation while maintaining the original Taxotere formulation. | ||||
| erlotinib (Tarceva) | Roche | tbc | Full submission | tbc |
Non-small cell lung cancer NSCLC | ||||
| gefitinib (Iressa) | Astra Zeneca Ltd | 13.12.10 | Resubmission | 11.10.10 |
Non-small cell lung cancer | ||||
| histamine dihydrochloride (Ceplene) | Meda Pharmaceuticals | tbc | Full submission | tbc |
Acute myeloid leukaemia in adults at first remission | ||||
| imatinib (Glivec) | Novartis Pharmaceuticals UK Ltd | 13.09.10 | Resubmission | 12.07.10 |
adjuvant GIST treatment | ||||
| pegylated interferon alfa 2b (Viraferon Peb) | MSD | tbc | Full submission | tbc |
For the treatment of children and adolescents who have chronic hepatitis C, not previously treated | ||||
| pemetrexed (Alimta) | Eli Lilly & Company Ltd | 11.10.10 | Full submission | 09.08.10 |
Non-small cell lung cancer | ||||
| trabectedin (Yondelis) | PharmaMar S.A | 13.09.10 | Full submission | 12.07.10 |
for the treatment of patients with relapsed platinum-sensitive ovarian cancer. | ||||
| trabectedin (Yondelis) | Pharma Mar | 08.11.10 | Resubmission | 13.09.10 |
Soft tissue sarcoma | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| certolizumab pegol (Cimzia) | UCB Pharma | 11.10.10 | Resubmission | 09.08.10 |
Rheumatoid arthritis | ||||
| febuxostat (Adenuric) | Menarini Pharma UK SRL | 13.09.10 | Full submission | 12.07.10 |
chronic hyperuricaemia in conditions where urate deposition has already occurred | ||||
| glucosamine sulphate sodium chloride (Glusartel) | HFA Healthcare Limited | 08.11.10 | Full submission | 13.09.10 |
for the treatment of OA of the knee. | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| eculizumab (Soliris) | Alexion Pharma UK Ltd. | 08.11.10 | Full submission | 13.09.10 |
Paroxysmal nocurnal haemoglobinuria | ||||
| ferric carboxymaltose (Ferinject) | Vifor Pharmaceuticals | tbc | Resubmission | tbc |
Iron deficiency | ||||
| filgrastim (Nivestim) | Hospira UK Limited | tbc | Full submission | tbc |
Rreduction in the duration of neutropenia and the incidence of febrile neutropenia (FN) in patients treated with established cytotoxic chemotherapy for malignancy | ||||
| lanthanum carbonate (Fosrenol) | Shire Pharmaceuticals Ltd | 11.10.10 | Full submission | 09.08.10 |
Hyperphosphataemia | ||||
| pegfilgrastim (Neulasta) | Amgen Ltd | tbc | Abbreviated Submission | |
Reduction in the duration of neutropenia | ||||
| sevelamer carbonate (Renvela) | Genzyme Therapeutics Ltd | 11.10.10 | Full submission | 09.08.10 |
control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. | ||||
| sevelamer carbonate (Renvela) | Genzyme Therapeutics Ltd | 08.11.10 | Full submission | 09.08.10 |
Hyperphosphataemia | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| ethinylestradiol and levonorgestrel 3 (TriRegol) | Consilient Health Ltd | 11.10.10 | Abbreviated Submission | 09.08.10 |
oral contraceptive | ||||
| ethinylestradiol 30mcg and levonorgestrel 150mcg (Rigevidon) | Consilent Health Ltd | 11.10.10 | Abbreviated Submission | 09.08.10 |
oral contraception | ||||
| ethinylestradiol and desogestrel (Gedarel) | Consilient Health Ltd | 11.10.10 | Abbreviated Submission | 09.08.10 |
oral contraceptive | ||||
| ethinylestradiol and gestodene (Millinette) | Consilient Health Ltd | 11.10.10 | Abbreviated Submission | 09.08.10 |
oral contraception | ||||
| etonogestrel (Nexplanon) | Merck Sharp & Dohme | 13.12.10 | Abbreviated Submission | 11.10.10 |
Contraception | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| roflumilast (Daxas) | Nycomed Ltd | 11.10.10 | Full submission | 12.07.10 |
maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients | ||||
| Drug Name | Manufacturer | Advice Due Date | Submission Type | Patient Interest Group Submission Deadline Date |
|---|---|---|---|---|
| tacrolimus (Modigraf) 0.2mg and 1mg granules | Astellas Pharma Ltd | TBC | Abbreviated Submission | TBC |
For treatment of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressives | ||||
| ustekinumab (Stelara) | Janssen-Cilag Ltd | tbc | Abbreviated Submission | tbc |
severe plaque psoriasis | ||||