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Our Pharmaceutical Products - Centre Spécialités Pharmaceutiques

 

We invite you to consult the list of our pharmaceutical products for which Centre Spécialités Pharmaceutiques is the Marketing Authorisation Operator.
On this page you will also find information about Adverse Event Reporting, and the associated documents for some of our pharmaceutical products (Risk Minimisation Measures, Compassionate Access Framework).

List of pharmaceutical products under marketing autorisation (MA) :

In accordance with article L.5121-1-3 of the French Public Health Code, please find below the list of pharmaceutical products for which CSP is the Marketing Authorisation Operator (MAO) “Exploitant”.

Download the full list
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CSP Pharmacovigilance: Reporting an adverse event

To report an adverse event, adverse drug reaction, incident or risk of incident related to a pharmaceutical product, you can report it to the Health Authorities on the ANSM website by clicking on the button below.

Report incident

Additional Risk Minimisation Measures

 

Pharmaceutical products with marketing authorisation in Centres Spécialités Pharmaceutiques with Additional Risk Minimisation Measures on national territory.

 

 

 

 

 

The so-called ‘routine’ risk minimisation measures provide a framework for the Safe Use of medicines. These include :

 

  • Information in the Summary of Product Characteristics (SmPC) for professionals and the patient information leaflet
  • Pharmaceutical product primary and secondary packaging
  • The introduction of prescribing and dispensing conditions

Where these appear insufficient to ensure safe and effective use, additional risk minimisation measures (aRMMs) may be implemented.

The following pharmaceutical products are subject to additional risk minimisation measures. Centre Spécialités Pharmaceutiques (CSP) advises patients and/or their relatives to consult their healthcare professional if they have not been given the appropriate tools or documents.

Compassionate Access Framework (CPC or Cadre de Prescription Compassionelle)

A Compassionate Access Framework (CPC in French) is run by Centre Spécialités Pharmaceutiques, local representative, acting in its capacity as Operator (“Exploitant”).

In compliance with the CPC established for Namuscla 167 mg, hard capsule, in application of article 5121-12-1 of the French Public Health Code, you can find below a reference to the protocol for the follow-up of patients treated with this medicine under the CPC.

Namuscla