WC500169468
WC500169468
WC500169468
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1. ANNEX I Risk Management Plans<br />
1.1. Medicines in the pre-authorisation phase<br />
As per agreed criteria, the PRAC endorsed without further plenary discussion the conclusions of the<br />
Rapporteur on the assessment of the RMP for the below mentioned medicines under evaluation for<br />
initial marketing authorisation application. Information on the medicines containing the below listed<br />
active substance will be made available following the CHMP opinion on their marketing<br />
authorisation(s).<br />
1.1.1. Balugrastim<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002637<br />
Intended indication: Treatment of chemotherapy-induced neutropenia<br />
1.1.2. Busulfan<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002806, Generic<br />
Intended indication: Conditioning treatment prior to conventional haematopoietic progenitor cell<br />
transplantation (HPCT)<br />
1.1.3. Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002705<br />
Intended indication: Control of serum phosphorus levels in patients with end-stage renal disease<br />
(ESRD)<br />
1.1.4. Netupitant, palonosetron<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/003728<br />
Intended indication: Prevention of acute and delayed chemotherapy-induced nausea and vomiting<br />
(CINV) induced by highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy<br />
(MEC)<br />
1.1.5. Obinutuzumab<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002799, Orphan<br />
Intended indication: Treatment of chronic lymphocytic leukaemia<br />
Applicant: Roche Registration Ltd<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/324055/2014 Page 51/73
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