- A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
- B. CONDITIONS OF THE MARKETING AUTHORISATION
- C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
- D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
- E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of themanufacturer(s) responsible for batch release
17, Parc des Vautes 34980 Saint Gély du Fesc France
Laboratoires CTRS 63, rue de l'Est
- Ocaliva - obeticholic acid
- Chenodeoxycholic acid leadiant (known as chenodeoxycholic acid sigma-tau) - chenodeoxycholic acid
- Kolbam - cholic acid
Prescription drugs listed. Substance: "Cholic acid"
B.CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic Safety Update Reports
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines
- Neofordex - Laboratoires CTRS
Prescription drugs listed. Manufacturer: "Laboratoires CTRS"
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
•At the request of the European Medicines Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
- Kolbam - A05AA03
Prescription drugs listed. ATC Code: "A05AA03"
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
•Additional risk minimisation measures
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors inprimary bile acid synthesis due to
The physician educational programme should contain the following key elements:
•Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
•Risk of gallstones
E. SPECIFIC OBLIGATION TO COMPLETE
POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
CTRS commits to monitor the safety and efficacy in patients treated with Orphacolfrom a
- first PSUR
patient surveillance database for which the protocol has been endorsed by the CHMP and is
- Annual Re-
documented in the Orphacol RMP.
The objectives of this surveillanceprogramme is to monitor accumulating data onefficacy
and safety in the treatment of inborn errors in primary bile acid synthesis due to
deficiency with Orphacol in infants, children, adolescents and adults.
Reports on recruitment progress of thepatient surveillance database will be analysed and
reported to the CHMP at the time of PSURs (for safety) and of the Annual
(for efficacy and safety). Progress and results from the database will form the basis of the
annual reassessments of the benefit/risk profile of Orphacol.