Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard - referral
bivalent HPV vaccine (types 16, 18)
quadrivalent HPV vaccine (types 6, 11, 16, 18)
9-valent HPV vaccine (types 6, 11, 16, 18, 31, 33, 45, 52 and 58)
Article 20 procedures
Associated names:
Cervarix
Gardasil
Gardasil 9
Silgard
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Oncept Melanoma
Date of withdrawal:
Last updated:
MedicineVeterinaryWithdrawn application
Protelos and Osseor - referral
strontium ranelate
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Omontys
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Medicines studied at Cetero Research facility - referral
fenofibrate
cilazapril
leflunomide
Article 31 referrals
Associated names:
Cilazapril Teva
Fenofibrato Pensa
Fenofibrato Ranbaxy
Leflunomide Actavis
Leflunomide Apotex
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Pending EC decisions on maximum residue limits

The European Medicines Agency (EMA) publishes summaries of opinion on maximum residue limits for active substances contained in veterinary medicines, which have been assessed by the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and are currently pending the adoption of a legally binding Regulation by the European Commission.

Last updated:
VeterinaryRegulatory and procedural guidanceMedicinesResearch and development
Maximum residue limit assessment reports

The European Medicines Agency (EMA) publishes assessment reports on maximum residue limits for active substances contained in veterinary medicines, which have been assessed by the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and are currently pending the adoption of a legally binding Regulation by the European Commission.

Last updated:
VeterinaryRegulatory and procedural guidanceMaximum residue limitMedicinesResearch and development
Ramelteon
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application