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Suspension of marketing authorisation for Parofor 175 mg/ml solution for injection for pigs

Notice type: Advisory

Date: 21/10/2019

 Consequent to the outcome of a referral procedure on veterinary medicinal products containing paromomycin that are administered by injection to pigs to the European Medicines Agency (EMA), the European Commission adopted a decision that requires Member States to suspend national marketing authorisations for the products concerned. The procedure was undertaken to consider differences in the approved indications, dosage, and withdrawal periods in respect of similar injectable products that were authorised nationally.

Product name or type:
Parofor 175 mg/ml Solution for Injection for pigs

Reference:
Safety Advisory Notice concerning the suspension of the marketing authorisation for Parofor 175 mg/ml solution for injection for pigs

Authorisation Number:
VPA 10782/031/001

Active Substance:
Paromomycin sulfate

Product Classification:
Antimicrobial

Serial Or Batch Number And Expiry Date:
N/A

Authorisation Holder:
Huvepharma NV, Belgium

Prescription Required:
Yes

Target Audience:
Veterinary practitioners and pharmacists

Problem Or Issue:
Following a referral procedure to the EMA that was initiated by Belgium, the CVMP considered that the use of veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not supported by pre-clinical, clinical and residue depletion data and currently recommended indications, dosing regimens and withdrawal period could pose a potential risk to animal and human health, and therefore the benefit-risk assessment is negative. 

Background Information Or Related Documents:
Further documents explaining the rationale of the CVMP opinion will be uploaded to the EMA website within 4 weeks of the European Commission decision of 11 October 2019.

Actions To Be Taken:
Veterinary practitioners should not prescribe injectable products containing paromomycin, pending the lifting of the suspension of the marketing authorisation (which is dependent on new information being made available to address the CVMP concerns).

Further Information:
This is a prescription only medicine that contains an aminoglycoside antibiotic for pigs. The action being taken is a precautionary approach on the basis of inadequate information on the safety and efficacy of the product concerned. The CVMP identified a potential risk that product administration at the currently recommended dose will lead to ineffective treatment and risk of antimicrobial resistance development. The HPRA understands that the product is not being marketed currently.

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