# C_2022215EN.01001201.xml

| 31.5.2022 | EN | Official Journal of the European Union | C 215/12 |
| --- | --- | --- | --- |

31.5.2022

EN

Official Journal of the European Union

C 215/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1)
  , Article 38 of Directive 2001/82/EC (2)
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3)
  )

(2022/C 215/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 1.4.2022 | Nasolam and associated names | midazolam | See Annex | See Annex | 4.4.2022 |

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

1.4.2022

Nasolam and associated names

midazolam

See Annex

See Annex

4.4.2022

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

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ANNEX

List of medicinal products and presentations

| Member State EU/EEA | Applicant
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | Tiofarma B.V. |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Denmark

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Denmark

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Denmark

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Finland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg, Nasenspray, Lösung im Einzeldosisbehältnis

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg, Nasenspray, Lösung im Einzeldosisbehältnis

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Germany

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg, Nasenspray, Lösung im Einzeldosisbehältnis

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Ireland

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg neusspray, oplossing in een verpakking voor éénmalig gebruik

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg neusspray, oplossing in een verpakking voor éénmalig gebruik

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

The Netherlands

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg neusspray, oplossing in een verpakking voor éénmalig gebruik

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Norway

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

Sweden

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

United Kingdom (Northern Ireland)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Nasal spray, solution in single-dose container

Nasal use

50 mg/ml

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(1)  Invented name not accepted by National Competent Authority, pending new proposal by the applicant

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