🇪🇺 omeprazole, caffeine, flurbiprofen, rosiglitazone in European Union

EMA authorised omeprazole, caffeine, flurbiprofen, rosiglitazone on 11 July 2000

Marketing authorisations

EMA — authorised 11 July 2000

  • Application: EMEA/H/C/000269
  • Marketing authorisation holder: SmithKline Beecham Plc
  • Local brand name: Nyracta
  • Indication: Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:- in combination with metformin particularly in overweight patients.­- in combination with a sulphonylurea only in patients who
  • Status: withdrawn

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EMA — authorised 11 July 2000

  • Application: EMEA/H/C/000270
  • Marketing authorisation holder: SmithKline Beecham Plc
  • Local brand name: Venvia
  • Indication: Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea: in combination with metformin particularly in overweight patients. in combination with a sulphonylurea only in patients who s
  • Status: withdrawn

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EMA — authorised 27 June 2006

  • Application: EMEA/H/C/000675
  • Marketing authorisation holder: SmithKline Beecham Ltd
  • Local brand name: Avaglim
  • Indication: AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
  • Status: withdrawn

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omeprazole, caffeine, flurbiprofen, rosiglitazone in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is omeprazole, caffeine, flurbiprofen, rosiglitazone approved in European Union?

Yes. EMA authorised it on 11 July 2000; EMA authorised it on 11 July 2000; EMA authorised it on 27 June 2006.

Who is the marketing authorisation holder for omeprazole, caffeine, flurbiprofen, rosiglitazone in European Union?

SmithKline Beecham Plc holds the EU marketing authorisation.