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Administrative details:
Product number(s): EMEA/H/C/002749
Intended indication: Radiolabelling of carrier molecules
14.1.7. Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches
Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Administrative details:
Product number(s): EMEA/H/C/002705
Intended indication: Control of serum phosphorus levels in patients with end-stage renal disease
(ESRD)
14.1.8. Naloxegol
Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Administrative details:
Product number(s): EMEA/H/C/002810
Intended indication: Treatment of adult patients 18 years and older with opioid-induced constipation
(OIC) including patients with inadequate response to laxatives
14.1.9. Ramucirumab
Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Administrative details:
Product number(s): EMEA/H/C/002829, Orphan
Intended indication: Treatment of gastric cancer
14.1.10. Tedizolid
Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Administrative details:
Product number(s): EMEA/H/C/002846
Intended indication: Treatment of complicated skin and soft tissue infections (cSSTI) in adults
Medicines already authorised
As per agreed criteria, the PRAC endorsed without further plenary discussion the conclusions of the
Rapporteur on the assessment of these updated versions of the RMP for the below mentioned
medicines.
RMP in the context of a variation 36 – PRAC-led procedure
14.1.11. Adalimumab – HUMIRA (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Ulla Wändel Liminga (SE)
Administrative details:
Procedure number(s): EMEA/H/C/000481/II/0130
Procedure scope: Update of the RMP (version 11.1)
36 In line with the revised variation regulation for submissions as of 4 August 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 50/75