Immunological data

IMMUNOLOGICAL PROPERTIES

Immunological properties

Pharmacotherapeutic group

Immunological veterinary medicinal products

For immunobiological products for veterinary use

Immunological Haemolysis

Details of all CVMP guidelines are given in Annex 10.

Pastoret and has been

management of pharmacovigilance information and data following implementation of EudraVigilance

18 20 Immunological properties

The four Working Parties, including the joint CPMP CVMP Quality Working Party, have met regularly throughout the year.

Immunologicals Working Party

Non immunological haemolysis

s Very dissatisfied s Satisfied

(Pompe's disease)

CVMP Immunologicals Working Party

CVMP Immunologicals Working Party Document title Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products

Immunological haemolysis due to ABO incompatibility

Immunological haemolysis due to other allo antibody

Immunological Veterinary Medicinal Products

(C5H5)2Ti(CO)2.

In addition, Parliament approved the common position on the pricing of medicinal products10

Analyses of data through 96 weeks of treatment in the three POWER trials demonstrated sustained antiretroviral efficacy and immunological benefit.

This policy clarifies the fees due for these inspections.

to complete drafting of the following guidelines on immunological veterinary medicinal products

3.9 Working parties and ad hoc groups Immunologicals Working Party

Contribution to the international harmonisation of technical requirements for immunologicals

For all products for human and veterinary use (except immunological products for veterinary use)

uncommon

Plasma derived pharmaceuticals 2 These products are only included within the product coverage of this Annex to the extent the Joint Sectoral Committee decides to include them pursuant to Article 20.

In the case of immunological veterinary medicinal products, the fee shall be EUR 5800.

Venous disorder

7

Lymphoma like disorder

Cerebrovascular disease

Chest pain Influenza like illness Drug ineffective

Chest pain Influenza like illness

flu like illness

Very rare Body as a whole anaphylaxis, serum sickness Cardiovascular syncope, hypotension Central and peripheral nervous system paralysis, neuropathy, neuritis (including Guillain Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, convulsions Haematological disorder thrombocytopenia

Parkinson s disease Dosing in patients with early stage Parkinson s disease

Eye disorders corneal epithelium disorder, corneal disorder, visual disturbance, eye swelling, eye allergy, madarosis, eyelid disorder, eyelid oedema, erythema of eyelid

Patients treated with ATryn should be monitored for possible clinical immunological reactions.

Close surveillance with regard to immunological reactions is especially important in such situations.

The Working Party met four times during 2002 and completed the revision of the guideline on safety evaluation of antimicrobial substances regarding the effects on human gut flora.