Postmarketing non-interventional safety study on medicinal product Buprenorphine Actavis 35; 52,5; 70 microgram/h transdermal patch in Czech Republic, No.1303010000

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Patient´s and treatment characteristics

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Buprenorphine Actavis 35, 52,5, 70 mikrogramů/h transdermální náplast
• Study drug International non-proprietary name (INN) or common name:
  BUPRENORPHINE
• Anatomical Therapeutic Chemical (ATC) code:
  (N02AE01) buprenorphine

  buprenorphine

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  675

Study design details

• Main study objective:
  Obtaining information about safety of the drug and patient´s characterstics.
• Data analysis plan:
  Query investigation with statistical evaluation of results.