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SAFETY NOTICE Concerning two Homeopathic Medicinal Products for Ophthalmic Use

Notice type: Advisory

Date: 04/10/2006

  

Product name or type:
Revitorgan Conisan A Eye Drops and Revitorgan Conisan B Eye Drops

Manufacturer Or Supplier:
Vitorgan Arzneimittel Gmbh (Germany)

Serial Or Batch Number And Expiry Date:
Revitorgan Conisan A Eye Drops, Batch No. 1200, EXP. 06.2007 
Revitorgan Conisan B Eye Drops, Batch No. 1260, EXP. 09/2007

Authorisation Holder:
Vitorgan Arzneimittel Gmbh (Germany)

Problem Or Issue:
The Irish Medicines Board (IMB) has recently been informed by the Italian Medicines Agency that batches of the following two Homeopathic Medicinal Products have been associated with a serious ocular adverse event in Italy.  

This serious ocular adverse event concerned a microbial (Pseudomonas aeruginosa) eye infection in one patient.  

These products are reported to contain bovine foetal extracts.  The manufacturer of, and the Marketing Authorisation Holder for, these products is Vitorgan Arzneimittel Gmbh (Germany).  The Italian Medicines Agency has prohibited the sale of these two products in Italy.  

These products are not authorised in Ireland.  While Ireland has not been identified as a market for these two products, there is no conclusive evidence that these products are not on the market here.  

As a precautionary measure, therefore, the IMB has today communicated with various relevant trade organisations and professional bodies about the issue, so that their members, who may be wholesaling, selling or using these products, can be made aware of this information.  

Background Information Or Related Documents:
SAFETY NOTICE Concerning two Homeopathic Medicinal Products for Ophthalmic Use Document

Actions To Be Taken:
The IMB requests anyone who is wholesaling, selling or using any of these products to quarantine any packs of any batches of these products which they have in their possession, and to contact the IMB at the contact details shown below.  

Patients who received any of these products are advised to cease taking the product in question and to consult with their doctor. When speaking to their doctor, patients may find it helpful to take a copy of this IMB notification with them. They should continue to take any medication prescribed by their doctor.  

Further Information:
The HPRA contact person for this issue is:   

Kevin O' Donnell, 
Market Compliance Manager, 
Health Products Regulatory Authority, 
Kevin O’Malley House, 
Earlsfort Terrace, Dublin 2, 
Ireland   Tel:   +353-1-6764971 (office) 
Tel:   +353-87-9562818 (mobile) 
Fax:  +353-1-6764061    

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