Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Onivyde   
Auth. number : EU/1/16/1130
Active substance : irinotecan
Orphan market exclusivity for "Treatment of pancreatic cancer" (based on designation EU/3/11/933) started on 18/10/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 18/10/2026
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX19 - irinotecan
(See WHO ATC Index)
Indication: Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Marketing Authorisation Holder: Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/10/2016 Centralised - Authorisation EMEA/H/C/4125 (2016)6778 of 14/10/2016
22/05/2017 Centralised - Notification EMEA/H/C/4125/N/3
Updated with Decision(2018)8682 of 07/12/2018
11/12/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4125/T/12 (2018)8682 of 7/12/2018
16/01/2019 PSUSA - Modification EMEA/H/C/4125/PSUSA/10534/201804 (2019)259 of 14/01/2019
4/02/2019 Centralised - 2-Monthly update EMEA/H/C/4125/II/08 (2019)859 of 31/01/2019
29/03/2019 Centralised - Variation EMEA/H/C/4125/IAIN/14