Committee for medicinal products for human use (CHMP)

Emtricitabine/Tenofovir disoproxil Mylan -
emtricitabine / tenofovir disoproxil -
EMEA/H/C/004050
Applicant: MYLAN S.A.S, treatment of HIV,
Generic, Generic of Truvada, Generic application
(Article 10(1) of Directive No 2001/83/EC)
Ocaliva - obeticholic acid -
EMEA/H/C/004093, Orphan
Applicant: Intercept Pharma Ltd, treatment of
primary biliary cirrhosis, New active substance
(Article 8(3) of Directive No 2001/83/EC)
Pemetrexed ditromethamine Hospira -
Pemetrexed Ditromethamine -
EMEA/H/C/004306
Applicant: Hospira UK Limited, treatment of
malignant pleural mesothelioma and non-small
cell lung cancer, Generic application (Article
10(1) of Directive No 2001/83/EC)
Rekovelle - follitropin delta -
EMEA/H/C/003994
Applicant: Ferring Pharmaceuticals A/S, indicated
for controlled ovarian stimulation, New active
substance (Article 8(3) of Directive No
2001/83/EC)
SomaKit TOC - edotreotide -
EMEA/H/C/004140, Orphan
Applicant: Advanced Accelerator Applications,
Diagnosis of gastro-entero-pancreatic
neuroendocrine tumours, Well-established use
application (Article 10a of Directive No
2001/83/EC)
Tenofovir disoproxil Mylan - tenofovir
disoproxil - EMEA/H/C/004049
Applicant: MYLAN S.A.S, treatment of HIV-1
infection and hepatitis B infection, Generic,
Generic of Viread, Generic application (Article
10(1) of Directive No 2001/83/EC)
Venclyxto - venetoclax -
EMEA/H/C/004106, Orphan
Applicant: AbbVie Ltd., treatment of adult
patients with chronic lymphocytic leukaemia
(CLL), New active substance (Article 8(3) of
Directive No 2001/83/EC)
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 7/43