Eksempler på brug af Referral procedure på Engelsk og deres oversættelser til Dansk
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During the referral procedure Dr.
Simultaneously, the MAH updated module 3 was updated to CTD format in this referral procedure.
The referral procedure started on 27 July 2006.
All other sections of the SPC were harmonised as a result of the referral procedure except See Below; Administrative Issues.
The referral procedure started on 26 June 2003.
Include the 15 hypospadias cases from the SMBR, and8 spontaneous reports that were received following the initiation of the Article 31 referral procedure.
The referral procedure started on 11 July 2007.
The Council and the Commission consider that, when a specific market represents a substantial part of the common market, the referral procedure provided for in Article 9 should only be applied in exceptional cases.
The referral procedure started on 20 January 2005.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I andphase II assessment and the referral procedure in CMD(v) thereafter.
The referral procedure started on 30 May 2002.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I andphase II assessment and the referral procedure in CMD(v) thereafter.
The referral procedure started 26 April 2002.
Therefore, the CHMP and the Applicant/ MAH were in agreement with the proposal to adapt the national SPCs of Ciprofloxacin MR tablets in those European Member States where the product is approved,to the outcome of the referral procedure for the other Ciprofloxacin Bayer formulations by submitting adequate national variations.
The referral procedure started on 29 April 2005.
These issues were referred to the CHMP during the referral procedure under Article 29 of Directive 2001/ 83/ EC, as amended, on 26 April 2007.
This referral procedure relates to a request for arbitration concerning the benefit/ risk of the 90mg dose of etoricoxib in the treatment of RA and ankylosing spondylitis AS.
Other Sections of the SPC The following sections of the SPC were also subject to extensive harmonisation during this referral procedure, namely sections 4.4 Special warnings and precautions, 4.5 Interactions, 4.6 Pregnancy and lactation, 4.8 Undesirable effects, 4.9 Overdose, 5.1 Pharmacodynamic properties, and 5.2 Pharmacokinetic properties.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the“ reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
The CVMP started the referral procedure during its meeting of 15-17 January 2008.
The referral procedure was triggered by Spain and The Netherlands, who were of the opinion that this medicinal product might present a risk to public health since the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the“ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors”.
The referral procedure started on 17 March 2005.
The referral procedure started on 23 January 2003.
The referral procedure started on 21 April 2005.
The referral procedure started on 21 September 2006.
The referral procedure started 25 September 2003.
The referral procedure started on 19 September 2005.
The referral procedure started on 19 September 2005.