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Procedure scope: Introduction of a new pharmaceutical form: 100 mg/ml solution for injection
presented in vials containing 0.5 ml and 1 ml
MAH(s): AbbVie Ltd.
14.1.38. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
ADJUPANRIX (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
Administrative details:
Procedure number(s): EMEA/H/C/001206/II/0034
Procedure scope: Update of SmPC section 4.4 to include a statement regarding the observed increased
risk of narcolepsy following vaccination with Pandemrix, the MAH's ASO3 adjuvanted H1N1 influenza
vaccine, based on a review of epidemiologic or post-marketing surveillance
MAH(s): GlaxoSmithKline Biologicals S.A.
14.1.39. Pneumococcal polysaccharide conjugate vaccine (adsorbed) – SYNFLORIX (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
Procedure number(s): EMEA/H/C/000973/II/0079
Procedure scope: Update of SmPC section 5.1 to reflect the results of the phase III/IV clinical trial
(Finnish Invasive Pneumococcal disease vaccine) to evaluate the effectiveness of Synflorix (against
reduction of hospital-diagnosed pneumonia, and impact on tympanostomy tube placements and
outpatient antimicrobial prescriptions) to address a post-authorisation measure
MAH(s): GlaxoSmithKline Biologicals S.A.
14.1.40. Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
PREPANDRIX (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
Administrative details:
Procedure number(s): EMEA/H/C/000822/II/0051
Procedure scope: Update of SmPC to include a statement regarding the observed increased risk of
narcolepsy following vaccination with Pandemrix, the MAH's ASO3 adjuvanted H1N1 influenza vaccine,
based on a review of epidemiologic or post-marketing surveillance
MAH(s): GlaxoSmithKline Biologicals S.A.
14.1.41. Pyronaridine, artesunate – PYRAMAX (Art 58)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/W/002319/II/0002
Procedure scope: Changes to SmPC section 4.1 to remove restrictions on repeated course of treatment
in any individual and use only in areas of low transmission with evidence of artesmisinin resistance,
based on further clinical experience. Consequent changes in SmPC sections 4.2, 4.4, 4.8. Change is
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 57/75