Lokelma 5 g powder for oral suspension
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 September 2026
File name
20260901 Package leaflet IE MT Lokelma 5g 10g launch of 90-day pack Germany CV 26 0011.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
6. Contents of the pack and other information
What Lokelma looks like and contents of the pack
....
The sachets are supplied in a carton containing 3, or 30, or Multipack containing 90 (3 packs of 30) sachets.
Marketing Authorisation Holder
Manufacturer
....
AstraZeneca AB
Karlebyhusentren Astraallen,
SE-152 57 Södertälje
Sweden
This leaflet was last revised in 09/2026
Other sources of information
Detailed information on this medicine is also available on the European Medicines Agency web site: https://www.ema.europa.eu
Updated on 07 September 2026
File name
20260901 SPC IE MT Lokelma 5g 10g launch of 90-day pack Germany CV 26 0010.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.5 Nature and contents of container
5 or 10 g of powder in sachets made of a PET/alu/LLDPE or PET/LDPE/alu/EAA/LLDPE laminate
Pack sizes: 3, or 30, or Multipack containing 90 (3 packs of 30) sachets
Not all pack sizes may be marketed.
8. MARKETING AUTHORISATION NUMBER(S)
.....
EU/1/17/1173/013
10. DATE OF REVISION OF THE TEXT
01 September 2026
Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu
Updated on 26 August 2025
File name
20250724 Package leaflet IE MT Lokelma 5g 10g HF CDS CV 25 0012.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 26 August 2025
File name
20250724 SmPC IE MT Lokelma 5g 10g HF CDS CV 25 0011.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 February 2025
File name
20240927 SPC IE MT Lokelma 5g 10g CV 24 0022.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New SPC for new product
Updated on 26 February 2025
File name
20240927 Package Leaflet IE MT Lokelma 5g 10g CV 24 0023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product
AstraZeneca Pharmaceuticals (Ireland) DAC
 DAC.webp)
Address:
College Business and Technology Park, Blanchardstown Road North, Dublin 15, D15 R925Medical Information E-mail:
mipqc.ireland@astrazeneca.comTelephone:
+353 1 609 7100Fax:
+353 1 686 5038Website:
https://contactazmedical.astrazeneca.comMedical Information Direct Line:
1800 800 899