Dany's BienenWohl

oxalic acid dihydrate

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An overview of Dany’s BienenWohl and why it is authorised in the EU

Dany’s BienenWohl is a medicine used to treat varroosis in honey bee colonies. Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor). The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees. The mite can also help spread viruses and bacteria. A significant mite infestation can lead to the collapse of a honey bee colony. Dany’s BienenWohl can only be used on colonies without brood and should be used as part of a wider management programme. If possible, the use of Dany’s BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.

Dany’s BienenWohl contains the active substance oxalic acid. This medicine is the same as Oxybee, which is already authorised in the European Union (EU). The company that makes Oxybee has agreed that its scientific data can be used for Dany’s BienenWohl (‘informed consent’).

How is Dany’s BienenWohl used?

Dany’s BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription. Up to 6 ml of Dany’s BienenWohl are trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C. The dispersion should be warmed to 30-35˚C before application.

For more information about using Dany’s BienenWohl, see the package leaflet or contact your veterinarian or pharmacist.

How does Dany’s BienenWohl work?

How oxalic acid works on mites is not well understood but it is thought that the activity of oxalic acid on mites is due to the acidity of the medicine, which kills the mites on contact.

What benefits of Dany’s BienenWohl have been shown in studies?

The effectiveness of Dany’s BienenWohl against varroa mites was investigated in two field studies in European countries with different climates. In the first study treatment with Dany’s BienenWohl was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Dany’s BienenWohl was compared to a group with no treatment. Three weeks of treatment Dany’s BienenWohl led to the death of 97 and 95 % of the mites.

What are the risks associated with Dany’s BienenWohl?

The most common side effect with Dany’s BienenWohl (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths. This did not affect long-term development of colonies.

For the full list of restrictions, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Dany’s BienenWohl is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose). Contact with these areas should be avoided, both directly and by hand-to-mouth or hand-to-eye contact. Protective clothing, acid resistant gloves and safety glasses should be worn during treatment. Contaminated clothing should be removed immediately. Hands and exposed skin should be washed with soap and plenty of water immediately. People must not eat, drink or smoke while using the medicine. Used measuring devices and empty containers should be disposed of immediately in a safe way.

If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced. In case of eye contact, the affected eye should be rinsed thoroughly with water (contact lenses should be removed first). Medical advice should be sought immediately and the package leaflet or label shown to the doctor.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.

The withdrawal period for honey from honey bees treated with Dany’s BienenWohl is ‘zero’ days, which means that there is no mandatory waiting time.

Why is Dany’s BienenWohl authorised in the EU?

The European Medicines Agency concluded that Dany’s BienenWohl’s benefits are greater than its risks and it can be authorised for use in the EU.

Other information about Dany’s BienenWohl

Dany’s BienenWohl received a marketing authorisation valid throughout the EU on 14 June 2018.

This authorisation was based on the authorisation granted to Oxybee in 2018 (‘informed consent’).

Further information on Dany’s BienenWohl can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.

Name Language First published Last updated
Dany's BienenWohl : EPAR - Summary for the public BG = bălgarski 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public ES = español 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public CS = čeština 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public DA = dansk 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public DE = Deutsch 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public ET = eesti keel 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public EL = elliniká 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public EN = English 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public FR = français 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public IT = italiano 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public LV = latviešu valoda 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public LT = lietuvių kalba 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public HU = magyar 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public MT = Malti 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public NL = Nederlands 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public PL = polski 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public PT = português 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public RO = română 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public SK = slovenčina 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public SL = slovenščina 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public FI = suomi 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public SV = svenska 2018-07-17  
Dany's BienenWohl : EPAR - Summary for the public HR = Hrvatski 2018-07-17  

This EPAR was last updated on 17/07/2018 .

Authorisation details

Product details

Product details for Dany's BienenWohl
NameDany's BienenWohl
Agency product numberEMEA/V/C/004667
Active substance

oxalic acid dihydrate

International non-proprietary name (INN) or common name

oxalic acid dihydrate

Species Bees
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53AG03



Publication details

Publication details for Dany's BienenWohl
Marketing-authorisation holder

Dany Bienenwohl GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union14/06/2018

Contact address:

Dany Bienenwohl GmbH
Geyerspergerstrasse 27 80689
Munich
Germany

Product information

Product information

14/06/2018  Dany's BienenWohl -EMEA/V/C/004667

Name Language First published Last updated
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - Product Information HR = Hrvatski 2018-07-17  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  
Dany's BienenWohl : EPAR - All Authorised presentations HR = Hrvatski 2018-07-17  

Pharmacotherapeutic group

Ectoparaciticides, insecticides and repellents

Therapeutic indication

For the treatment of varroosis (Varroa destructor) of honey bees (Apis mellifera) in brood free colonies.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Dany's BienenWohl : EPAR - Public assessment report HR = Hrvatski 2018-07-17  
CVMP summary of positive opinion for Dany's BienenWohl HR = Hrvatski 2018-04-20  

Authorised

This medicine is approved for use in the European Union