Otomicol 23 mg/ml + 5 mg/ml + 5500 IE/ml Ohrentropfen und Suspension zur Anwendung auf der Haut für Hunde, Katzen und Meerschweinchen - Zusammengefasste Informationen

The VMP contains 23 mg miconazole nitrate, 5500 IU polymyxin B sulfate and 5 mg prednisolone acetate as active substances and the excipients colloidal anhydrous silica and liquid paraffin.

The container/closure system is presented in 15 ml white LDPE bottles with white LDPE dropper and white HDPE closure. The secondary packaging is a printed carton.

The choice of the formulation is justified.

The VMP is an established pharmaceutical form and its development is adequately described in accordance with the relevant European guidelines.

The VMP is manufactured fully in accordance with the principles of good manufacturing practice at a licensed manufacturing site.

Process validation data on the VMP have been presented in accordance with the relevant European guidelines.

The active substances miconazole nitrate, polymyxin B sulfate and prednisolone acetate, are established substances described in the European Pharmacopeia. The active substances are manufactured in accordance with the principles of good manufacturing practice.

The active substance specifications are considered adequate to control the quality of the material. Batch analytical data demonstrating compliance with the specifications have been provided.

There are no substances within the scope of the TSE Guideline present or used in the manufacture of this VMP.

Not applicable.

The finished product specification controls the relevant parameters for the pharmaceutical form. The tests in the specification and their limits have been justified and are considered appropriate to adequately control the quality of the VMP.

Satisfactory validation data for the analytical methods have been provided.

Batch analytical data from the proposed production site have been provided demonstrating compliance with the specification.

Stability data on the active substances have been provided in accordance with applicable European guidelines, demonstrating the stability of the active substance when stored under the approved conditions.

Stability data on the finished product have been provided in accordance with applicable European guidelines, demonstrating the stability of the VMP throughout its shelf life when stored under the approved conditions.

Not applicable.

3. SAFETY DOCUMENTATION (safety and residues tests)

As this is a hybrid application according to Article 19 of Regulation (EC) 2019/6 and essential similarity to a reference VMP has been demonstrated, results of safety tests are not required.

The safety aspects of this VMP are identical to the reference VMP.

Warnings and precautions as listed in the product literature are comparable to those of the reference VMP. A warning in respect to children has been added. The safety phrases are adequate to ensure safety of the product to the user and the environment.

This application has been submitted in accordance with Article 19(1) of Regulation (EU) 2019/6). As essential similarity is accepted and safety has been evaluated for the reference product, the applicant is not required to provide safety data.

Development of resistance and related risk in humans

The applicant has provided bibliographical information regarding the level of resistance in target pathogens which show that the prevalence of resistance remains acceptable across the EU.

Warnings and precautions as listed on the product literature are adequate to ensure prudent and responsible use of the VMP.

In comparison to the reference product, no increase in environmental exposure and no change in the risk of resistance development is to be expected associated with the use of Otomicol, ear drops and cutaneous suspension.

User safety

The applicant has provided a user safety assessment in compliance with the relevant guideline. However, this veterinary medicinal product is a hybrid generic product of the reference product Surolan with the same qualitative and quantitative composition, the same pharmaceutical form, intended to be used in the same species, for the same indications and in the same doses. Therefore, the user safety of Miconazole/Pred­nisolone/Poly­myxin ear drops, suspension is considered the same as those of its reference product. However, an unacceptable risk to children has been identified for miconazole and prednisolone following accidental ingestion of 1.5 ml of the product which is 10% of the bottle (without a child resistant closure). A special warning for children was therefore added.

Warnings and precautions as listed on the product literature are adequate to ensure safety to users of the VMP.

Environmental Risk Assessment

A Phase I environmental risk assessment (ERA) was provided according to the CVMP/VICH guidelines.