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Orphacol (cholic acid) – Conditions or restrictions regarding supply and use - A05AA03

Updated on site: 09-Oct-2017

Medication nameOrphacol
ATC CodeA05AA03
Substancecholic acid
ManufacturerLaboratoires CTRS

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of themanufacturer(s) responsible for batch release

Amatsi

17, Parc des Vautes 34980 Saint Gély du Fesc France

or

Laboratoires CTRS 63, rue de l'Est

92100 Boulogne-Billancourt France

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 web-portal.

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.

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 3β-Hydroxy- 5-C27-steroid oxidoreductase deficiency or 4-3-Oxosteroid-5β-reductase deficiency and to inform on expected and potential risksassociated with the treatment.

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:

Description

Due Date

 

 

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.

assessment

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

 

3β-Hydroxy- 5-C27-steroid oxidoreductase deficiency or 4-3-Oxosteroid-5β-reductase

 

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 Re-assessments

 

(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.

 

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