Examples of Celgene Europe in a sentence
This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Revlimid 5 mg, 10 mg, 15 mg and 25 mg hard capsules (EU/1/07/391) which has been registered in the EEA by Celgene Europe Ltd since 19 June 2006.
IV.2 Pharmacokinetics The MAH conducted a bioequivalence study in which the pharmacokinetic profile of the test product Lenalidomide Synthon 25 mg hard capsules (Synthon BV, The Netherlands) is compared with the pharmacokinetic profile of the reference product Revlimid 25 mg hard capsules (Celgene Europe Limited).
This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Revlimid 5 mg, 10 mg, 15 mg and 25 mg hard capsules (EU/1/07/391) which has been registered in the EEA by Celgene Europe Ltd since 19 June 2006 via a centralised procedure.
As a consideration for this First Amendment and as a consideration for the Parties concurrently with this First Amendment entering into a Second Amended and Restated License Agreement in relation to the product known as bb21217, Celgene Europe shall make a one-time, non-refundable, non-creditable cash payment of two hundred million dollars ($200,000,000) to Bluebird within [***] of the First Amendment Effective Date.
The anti-coagulant lepirudin (Refludan) was obtained from Celgene Europe (Windsor, GB).
The following indications which are covered by orphan designation for the product Revlimid, were not applied for: Myelodysplastic syndromes (MDS) Mantle cell lymphoma (MCL) This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Revlimid hard capsules (EU/1/07/391), which has been registered in the EEA via a centralised procedure by Celgene Europe Ltd since 14 June 2007.
This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Revlimid 5 mg, 10 mg, 15 mg and 25 mg hard capsules (EU/1/07/391) which has been registered in the EEA by Celgene Europe B.V. since 19 June 2006.
IV.2 Pharmacokinetics The MAH conducted a bioequivalence study in which the pharmacokinetic profile of Lenalidomide Anabiosis 25 mg, hard capsules (Anabiosis PC., Greece) is compared with the pharmacokinetic profile of Revlimid 25 mg hard capsules (Celgene Europe Ltd, Germany).
IV.2 Pharmacokinetics The MAH conducted a bioequivalence study in which the pharmacokinetic profile of the test product Lenalidomide betapharm 25 mg hard capsules (Betapharm Arzneimittel GmbH, Germany) is compared with the pharmacokinetic profile of the reference product Revlimid 25 mg hard capsules (Celgene Europe B.V., the Netherlands).
Facsimile: 000-000-0000 If to Celgene: Celgene European Investment Company LLC Europe: c/o Celgene International Sarl Route de Perreux 1 2017 Boudry Switzerland Attention: Xxxxxx Xxxxx Facsimile: 011-41-32-729-8604 with copies to (in the case of Celgene Corp., Celgene Europe, or both): Celgene Legal 00 Xxxxxx Xxxxxx Summit, NJ 07901 Attention: General Counsel Telephone: (000) 000-0000 Facsimile: (000) 000-0000 and: Dechert LLP 000 Xxxxxxxx Xxxxxx Xxxxx 000 Xxxxxxxxx, XX 00000 Attention: Xxxxx X.