Pandemrix
Expired
This medicine's authorisation has expired
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
MedicineHumanExpired
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for the vaccine Pandemrix expired on 13 August 2015 following the decision of the marketing authorisation holder, GlaxoSmithKline Biologicals, not to apply for a renewal of the marketing authorisation. Pandemrix is a split virion, inactivated, adjuvanted pandemic influenza vaccine containing A/California/7/2009 (H1N1)v like strain (X-179A).
GlaxoSmithKline Biologicals confirmed that it did not apply for a renewal of the authorisation due to lack of demand for the vaccine. Pandemrix was granted marketing authorisation in the European Union (EU) on 12 August 2010 for prophylaxis of influenza caused by A (H1N1)v 2009 virus. The marketing authorisation was valid for 5 years.
Pandemrix was used extensively during the 2009 (H1N1)v pandemic, with over 30 million people vaccinated in the EU. Cases of narcolepsy were reported in people who had received the vaccine during the 2009 pandemic. Understanding the link between narcolepsy and Pandemrix remains the subject of investigations and may have implications for the future use of similar vaccines. Therefore, irrespective of the expiry of the marketing authorisation for Pandemrix, the marketing authorisation holder agreed with the Agency to continue to investigate narcolepsy in association with vaccination and will submit to the Agency for evaluation any relevant data generated by the company as well as independent parties.
GlaxoSmithKline Biologicals is the marketing authorisation holder for another pandemic vaccine, Adjupanrix, which is authorised in the EU for pandemic preparedness. GlaxoSmithKline Biologicals will maintain the marketing authorisation for Adjupanrix.
The European Public Assessment Report (EPAR) for Pandemrix will be updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0079
28/04/2016
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Pandemrix
- Active substance
- split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
- International non-proprietary name (INN) or common name
- influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Disease Outbreaks
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
Influenza vaccinesTherapeutic indication
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Pandemrix should be used in accordance with Official Guidance.
Assessment history
News on Pandemrix
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