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, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2022-05-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2022215EN.01001201.xml










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






(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.




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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






NASOLAM 5 mg nasal spray, solution in single dose container


5 mg


Nasal spray, solution in single-dose container


Nasal use


50 mg/ml






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