# C_2022176EN.01000801.xml

| 29.4.2022 | EN | Official Journal of the European Union | C 176/8 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

C 176/8

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2022 to 31 March 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2022/C 176/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 24.3.2022 | etifoxine | etifoxine | See Annex I | See Annex I | 25.3.2022 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

24.3.2022

etifoxine

etifoxine

See Annex I

See Annex I

25.3.2022

—   Refusal of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.3.2022 | Lidocain/Prilocain IDETEC and associated names | lidocaine/prilocaine | See Annex II | See Annex II | 29.3.2022 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

28.3.2022

Lidocain/Prilocain IDETEC and associated names

lidocaine/prilocaine

See Annex II

See Annex II

29.3.2022

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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ANNEX I

List of nationally authorised medicinal products

| Member State in EEA | Marketing authorisation holder | Product name | INN/Active substance + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Bulgaria | Biocodex | Стрезам | Etifoxine Hydrochloride 50 mg Capsule | Capsule, Hard | Oral Use |
| France | Biocodex | Stresam | Etifoxine Hydrochloride 50 mg Capsule | Capsule, Hard | Oral Use |
| Malta | Biocodex | Stresam | Etifoxine Hydrochloride 50 mg Capsule | Capsule, Hard | Oral Use |

Member State in EEA

Marketing authorisation holder

Product name

INN/Active substance + Strength

Pharmaceutical form

Route of administration

Bulgaria

Biocodex

Стрезам

Etifoxine Hydrochloride 50 mg Capsule

Capsule, Hard

Oral Use

France

Biocodex

Stresam

Etifoxine Hydrochloride 50 mg Capsule

Capsule, Hard

Oral Use

Malta

Biocodex

Stresam

Etifoxine Hydrochloride 50 mg Capsule

Capsule, Hard

Oral Use

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ANNEX II

List of medicinal products and presentations

| Member State
  EU/EEA | Applicant | Invented name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | INTERNATIONAL DRUG DEVELOPMENT |
| 104 boulevard Auguste Blanqui |
| 75013 Paris |
| France |

Member State

EU/EEA

Applicant

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Denmark

INTERNATIONAL DRUG DEVELOPMENT

104 boulevard Auguste Blanqui

75013 Paris

France

Lidocain/Prilocain IDETEC

lidocaine 25 mg/g + prilocaine 25 mg/g

Cream

Topical

The Netherlands

| INTERNATIONAL DRUG DEVELOPMENT |
| --- |
| 104 boulevard Auguste Blanqui |
| 75013 Paris |
| France |

INTERNATIONAL DRUG DEVELOPMENT

104 boulevard Auguste Blanqui

75013 Paris

France

Lidocaïne/Prilocaïne 5 % Focus, Crème

lidocaine 25 mg/g + prilocaine 25 mg/g

Cream

Topical

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