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Pulmicort 400 Turbohaler – Summary of Product Characteristics (SmPC) for healthcare professionals

Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) Details

The Summary of Product Characteristics (SmPC) is written for healthcare professionals. Patients will find plain advice in the patient information leaflet: how to take, side effects, other medicines, pregnancy and breast-feeding.

Medicine strength:
400 microgram/dose
Contains active substance:
ATC code:
Similar medicines:

Summary of Product Characteristics (SmPC) - Pulmicort 400 Turbohaler

1. Trade Name of the Medicinal Product

Not applicable

2. Qualitative and Quantitative Composition

Not applicable

3. Pharmaceutical Form

Not applicable

Clinical Particulars

4.1. Therapeutic Indications

Not applicable

4.2. Posology and Method of Administration

Not applicable

4.3. Contra-indications

Not applicable

4.4. Special Warnings and Precautions for Use

Not applicable

4.5. Interactions with other Medicaments and other forms of Interaction

Not applicable

4.6. Pregnancy and Lactation

Not applicable

4.7. Effects on Ability to Drive and Use Machines

Not applicable

4.8. Undesirable Effects

Not applicable

4.9. Overdose

Not applicable

Pharmacological Properties

5.1. Pharmacodynamic Properties

Not applicable

5.2. Pharmacokinetic Properties

Not applicable

5.3. Preclinical Safety Data

Not applicable

Pharmaceutical Particulars

6.1. List of Excipients

Not applicable

6.2. Incompatibilities

Not applicable

6.3. Shelf Life

Not applicable

6.4. Special Precautions for Storage

Not applicable

6.5. Nature and Contents of Container

Not applicable

6.6. Instruction for Use/Handling

Not applicable

Administrative Data

7. Marketing Authorisation Holder

Not applicable

8. Marketing Authorization Number

Not applicable

9. Date of First Authorisation/Renewal of Authorisation

Not applicable

10. Date of (Partial) Revision of the Text

Not applicable

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PLPI 20774/0207

MHRA data as of 13 October 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Pulmicort 400 Turbohaler

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Budesonide
Strength 400 microgram/dose
Pharmaceutical form Inhalation powder
How is it taken Inhalation
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Drug group (ATC)
  1. R Respiratory system drugs
    1. R03 Drugs for obstructive airway diseases
      1. R03B Other drugs for obstructive airway diseases, inhalants
        1. R03BA Glucocorticoid inhalants for obstructive airway disease
          1. R03BA02 budesonide
Marketing authorisation PLPI 18799/2669, PLPI 20774/0207
Codes BNF 03020000

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.1.0 of 12 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.