Procaine benzylpenicillin
Table of contents
Overview
Start of review concerning veterinary medicines containing procaine benzylpenicillin
EMA has started a review of veterinary medicines containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.
These medicines have been used widely throughout the EU for decades. It has been noticed that the authorised durations of treatment vary between the different products and based on available data not all of them might be appropriate to treat all claimed indications effectively. This could also lead to a risk of development of antimicrobial resistance.
Having considered this issue, the national veterinary medicines regulatory authority of Germany requested EMA’s veterinary medicines committee (CVMP) to assess its impact on the benefits and risks of veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.
EMA will now review the available data to determine if any action is necessary to protect animal or public health or the environment.
Key facts
| Approved name |
Procaine benzylpenicillin
|
| Current status |
Procedure started
|
| Reference number |
EMEA/V/A/145
|
| Type | |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
18/02/2022
|
All documents
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Procaine benzylpenicillin Article-82 referral - Start of review (PDF/77.73 KB)
First published: 23/02/2022
EMA/119698/2022 -
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Procaine benzylpenicillin Article-82 referral - Timetable for procedure under Article 82 of Regulation (EU) 2019/6 (PDF/98.61 KB)
First published: 23/02/2022
Last updated: 13/07/2023
EMA/CVMP/104861/2022 Rev. 1 -
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Procaine benzylpenicillin Article-82 referral - Notification (PDF/498.44 KB)
First published: 23/02/2022 -
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Procaine benzylpenicillin Article-82 referral - List of questions to be addressed by the marketing authorisation holders (PDF/84.54 KB)
First published: 23/02/2022
EMA/CVMP/104859/2022 -
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Procaine benzylpenicillin Article-82 referral - Annex I (PDF/616.82 KB)
First published: 23/02/2022
Last updated: 08/09/2022
EMA/116259/2022 -
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Procaine benzylpenicillin – Article-82 referral – CVMP List of questions to be addressed by the stakeholders (PDF/84.62 KB)
First published: 23/02/2022
EMA/CVMP/104860/2022 -
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Procaine benzylpenicillin Article-82 referral - Stakeholder submission form (PDF/1.25 MB)
First published: 23/02/2022
Consultation dates: 23/02/2022 to 09/09/2022
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)