Page 8 - Norgine Annual Report 2017

Products

In May, Norgine launched ZIVEREL in Austria, Belgium, Luxembourg
®
and Switzerland, building on the previous launches in Spain, Australia
and New Zealand. ZIVEREL is designed to protect and repair
®
oesophageal mucosa, offering relief from the symptoms of gastro-

In March, Norgine entered into an agreement with Noventure S.L. to oesophageal reflux.
distribute GELSECTAN in Spain, Portugal and Andorra. GELSECTAN is
®
®
a Class IIa marked medical device used as a treatment for irritable bowel
syndrome (IBS).

In June, Norgine launched LYMPHOSEEK in Denmark, the
®
Netherlands and the UK. LYMPHOSEEK was launched in Italy in
®
September. LYMPHOSEEK has been specifically designed to target,
®
In November, Norgine announced it had expanded its partnership with bind to and be retained in sentinel lymph nodes, the first lymph node
Apharm s.r.l. by entering into an exclusive distribution deal for ZIVEREL (or group of nodes) to which cancer cells are most likely to spread from
®
PLUS, a line extension of ZIVEREL . a primary tumour.
®

In June, Norgine announced that the US Food and Drugs administration
(FDA) had accepted the New Drug Application (NDA) for its novel
1 litre bowel preparation, PLENVU (NER1006). In October, Norgine
®
announced that the UK Medicines and Healthcare Regulatory Agency
(MHRA) granted marketing authorisation for PLENVU (NER1006)
®
for bowel cleansing in adults prior to any procedure requiring a clean
bowel. The approval was granted under the European Medicines
Agency decentralised procedure, with the UK as the reference state.
PLENVU was subsequently approved for use in Austria, Australia,
®
Belgium, Denmark, Finland, France, Iceland, Ireland, Italy, Portugal
and The Netherlands. PLENVU was made available in the UK in
®
November 2017. PLENVU is known as PLEINVUE in Austria and
®
the Netherlands.

Governance

In 2017, Norgine continued to operate and meet the strict regulatory requirements which govern
the pharmaceutical sector. Norgine seeks to always remain compliant with relevant laws,
regulations and the Norgine Business Code. All Norgine employees are expected to conduct
their duties according to the highest ethical and professional business standards.

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