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The Icelandic and Norwegian authorities are expected to grant corresponding national authorisations within 30 days of receiving the final commission decision. The NAM is viewed as a respected agency in the Mutual Recognition Procedure and is the leading agency in the EU as a reference state in the role of marketing authorisations. At 31 December 2005, Somatuline([R]) and Somatuline([R]) Autogel([R]) had marketing authorisations in over 50 countries (including 26 in Europe) for the treatment of acromegaly and neuroendocrine tumors and in six countries (including 2 in Europe) for the treatment of acromegaly alone. |
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