English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Ceplene (histamine dihydrochloride) – Conditions or restrictions regarding supply and use - L03AX14

Updated on site: 05-Oct-2017

Medication nameCeplene
ATC CodeL03AX14
Substancehistamine dihydrochloride
ManufacturerMeda AB

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Labiana Pharmaceuticals, S.L.U. C/ Casanova, 27-31

08757 Corbera de Llobregat (Barcelona) Spain

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

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 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.

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

Description

Due date

Evaluate Minimal Residual Disease (MRD) at baseline and follow-up in a clinical

Annual

study or registry, as appropriate, for the assessment of the anti-leukaemic activity

reports within

of Ceplene plus low dose Interleukin-2 in a sufficient number of adult patients

the annual re-

stratified by age greater or less than 60 years with Acute Myeloid Leukemia in First

assessment

Complete Remission

 

 

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed