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Search results (910)
Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP
English (EN) (275.49 KB - PDF)
Ketoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limits
English (EN) (147.59 KB - PDF)
Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
On 23 May 2012 the European Commission adopted a Regulation1 establishing maximum residue limits for azamethiphos in fin fish, valid throughout the European Union. These maximum residue limits were based on the favourable opinion and the assessment report adopted by the Committee for Medicinal Products for Veterinary Use.
English (EN) (258 KB - PDF)
Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP
English (EN) (265.9 KB - PDF)
Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis
During its meeting of 8-9 June 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/10/764 for Votubia (everolimus) as an orphan medicinal product for the treatment of tuberous sclerosis.
English (EN) (111.28 KB - PDF)
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Pomalidomide Celgene (pomalidomide) for the treatment of multiple myeloma
English (EN) (107.6 KB - PDF)
EU/3/19/2145: Public summary of opinion on orphan designation for risdiplam for the treatment of spinal muscular atrophy
On 26 February 2019, orphan designation (EU/3/19/2145) was granted by the European Commission to Roche Registration GmbH, Germany, for risdiplam for the treatment of spinal muscular atrophy.
English (EN) (183.64 KB - PDF)
Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Tobi Podhaler (tobramycin) for the treatment of Pseudomonas aeruginosa lung infection in cys...
During its meeting of 6-7 October 2010, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/03/140 for Tobi Podhaler (tobramycin) as an orphan medicinal product for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis.
English (EN) (122.63 KB - PDF)
Recommendation for maintenance of orphan designation at the time of marketing authorisation: NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) for the treatment of partial deep dermal and full-thickness...
During its meeting of 3-4 October 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/02/107 for NexoBrid (concentrate of proteolytic enzymes enriched in bromelain, previously known as purified bromelain) as an orphan medicinal product for the treatment of partial deep dermal and full thickness burns.
English (EN) (114.88 KB - PDF)
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome
During its meeting of 10-11 July 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/01/077 for Revestive (teduglutide) as an orphan medicinal product for the treatment of short bowel syndrome.
English (EN) (111.78 KB - PDF)