EMEA-002114-PIP01-16 - paediatric investigation plan

abacavir

lamivudine

efavirenz

Key facts

• Active Substance:
  • abacavir
  • lamivudine
  • efavirenz
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0191/2017
• PIP number:
  EMEA-002114-PIP01-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Lek Pharmaceuticals d.d.; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/06/2017

Decision

P/0191/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for abacavir / lamivudine / efavirenz (EMEA-002114-PIP01-16)

AdoptedReference Number: EMA/398222/2017