Martindale Pharma® Acetylcysteine 200mg/mL Injection

Main information

  • Trade name:
  • Martindale Pharma® Acetylcysteine 200mg/mL Injection 20% w/v Concentrate for infusion
  • Dosage:
  • 20% w/v
  • Pharmaceutical form:
  • Concentrate for infusion
  • Units in package:
  • Ampoule, glass, Type I 10x10 mL, 10 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • PharmaZell GmbH

Documents

Localization

  • Available in:
  • Martindale Pharma® Acetylcysteine 200mg/mL Injection 20% w/v Concentrate for infusion
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12794
  • Authorization date:
  • 31-07-2006
  • Last update:
  • 28-09-2017

Summary of Product characteristics: dosage,interactions,side effects

NEW ZEALAND DATA SHEET

Page 1 of 10

1

PRODUCT NAME

Acetylcysteine 200 mg/mL Injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Acetylcysteine 200 mg per mL (as N-acetylcysteine)

Each 10 mL ampoule contains 2 g N-acetylcysteine

Excipients with known effect:

Each 10ml of N-acetylcysteine for Infusion contains 322.6mg sodium.

For full list of excipients, see 6.1.

3

PHARMACEUTICAL FORM

Concentrate for Infusion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients:

who present within 15 hours after an acute overdose with a plasma paracetamol level on or above

a line joining points of 150 mg/L at 4h and 20 mg/L at 15h (see nomogram below) or

who have taken more than 200 mg/kg or 10 g (whichever is less) of sustained release paracetamol

or have one of two serum paracetamol levels taken four hours apart on or above a line joining

points of 150 mg/L at 4h and 20 mg/L at 15h (see nomogram below) or

who have taken an acute overdose of paracetamol with opiates or medicines with anticholinergic

effects and have one of two serum paracetamol levels taken four hours apart on or above a line

joining points of 150 mg/L at 4h and 20 mg/L at 15h (see nomogram below) or

where there is any doubt over the time of an acute overdose, irrespective of plasma paracetamol

level or

who present more than 15 hours after an overdose with abnormal liver biochemistry (INR >1.3

and/or ALT >150) or fulminant hepatic failure or

who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is

defined as an overdose of 200 mg/kg or 10 g (whichever is less) over a single 24 hour period or

150 mg/kg of 6 g (whichever is less) per 24 hour period for at least 48 hours.

4.2

Dose and method of administration

Acetylcysteine should be administered by intravenous infusion preferably using glucose 5% as the

infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.

NEW ZEALAND DATA SHEET

Page 2 of 10

The majority of patients should be treated with the three infusion schedule. However some patients may

require prolonged treatment.

Patients who have taken very large overdoses (e.g. 50 g of paracetamol), co-ingested opiates or

medicines with anticholinergic effects, or have taken modified release paracetamol should be assessed

at the end of the normal dose schedule. Treatment should be continued until aminotransferase levels are

improving, INR is 1.3 or less and there is no acidosis.

Dose in Adults

Acetylcysteine 200 mg/mL Injection is infused in three intravenous infusions containing different

doses. This will give a total dose of 300 milligrams/kg of Acetylcysteine infused over 21 hours.

INITIAL INFUSION: An initial dose of 150 milligrams/kg of Acetylcysteine diluted in 200 mL of 5%

glucose and infused over 60 minutes.

SECOND INFUSION: 50 milligrams/kg of Acetylcysteine in 500 mL of 5% glucose over the next 4

hours.

THIRD INFUSION: 100 milligrams/kg of Acetylcysteine in 1000 mL of 5% glucose over the next 16

hours.

The patient should therefore receive a total of 300 mg/kg over a 21 hour period.

NEW ZEALAND DATA SHEET

Page 3 of 10

The dose

should be calculated using the patient’s actual weight

to a ceiling of 110 kg for obese

patients.

Regimen

Dose 1

Dose 2

Dose 3

Fluid

200 mL 5% glucose or sodium

chloride 0.9%

500mL 5% glucose or sodium

chloride 0.9%

1000mL 5% glucose or sodium

chloride 0.9%

Duration

Infusion

60 minutes

4 hours

16 hours

Medicine

Dose

150 mg/kg N-acetylcysteine

50 mg/kg N-acetylcysteine

100 mg/kg N-acetylcysteine

Patient

weight

Dose

Ampoule

volume

Infusion

rate

Dose

Ampoule

volume

Infusion

rate

Dose

Ampoule

volume

Infusion

rate

mL/h

mL/h

mL/h

40-49

6750

2250

4500

50-59

8250

2750

5500

60-69

9750

3250

6500

70-79

11250

3750

7500

80-89

12750

4250

8500

90-99

14250

4750

9500

NEW ZEALAND DATA SHEET

Page 4 of 10

100-109

15750

5250

10500

>110

16500

5500

11000

Dose calculations are based on the weight in the middle of the band

Ampoule volume has been rounded up to the nearest whole number

Dose in Children

Children should be treated with the same doses and regimen as adults; however the quantity of

intravenous fluid used must be modified to take into account age and weight as fluid overload is a

potential danger.

The full course of treatment with acetylcysteine includes three consecutive intravenous infusions.

INITIAL INFUSION: An initial dose of 150 milligrams/kg of Acetylcysteine given as a 50 mg/mL

solution at a rate of 3 mL/kg/h.

SECOND INFUSION: 50 milligrams/kg of Acetylcysteine over the next 4 hours. Given as a

6.25 mg/mL solution at a rate of 2 mL/kg/h

THIRD INFUSION: 100 milligrams/kg of Acetylcysteine over the next 16 hours. Given as a

6.25 mg/mL solution at a rate of 1 mL/kg/h.

The dose

should be calculated using the patient’s actual weight.

Determine the total volume of

solution needed from the table.

Preparation of the solution

Initial infusion: To prepare a 50 mg/mL solution, dilute each 10 mL ampoule of acetylcysteine

(200 mg/mL) with 30 mL glucose 5% or sodium chloride 0.9% to a total volume of 40 mL.

Second infusion: To prepare a 6.25 mg/mL solution, dilute each 10 mL ampoule of acetylcysteine

(200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

Third infusion. To prepare a 6.25mg/mL solution, dilute each 10mL ampoule of acetylcysteine

(200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.

Regimen

Dose 1

Dose 2

Dose 3

Medicine

dose

150 mg/kg N-acetylcysteine

50 mg/kg N-acetylcysteine

100 mg/kg N-acetylcysteine

Duration of

Infusion

1 hour

4 hours

16 hours

Infusion

concentration

50 mg/mL

6.25 mg/mL

6.25 mg/mL

Rate of

infusion

3 mL/kg/h

2 mL/kg/h

1 mL/kg/h

Patient

weight

Dose

Rate

infusion

Total

infusion

volume

Dose

Rate

infusion

Total

infusion

volume

Dose

Rate

infusion

Total

infusion

volume

mL/h

mL/h

mL/h

1050

1200

NEW ZEALAND DATA SHEET

Page 5 of 10

1350

10-14

1875

1250

15-19

2625

1750

20-24

3375

1125

2250

25-29

4125

1375

2750

30-34

4875

1625

3250

35-39

5625

1875

3750

For example, for a child weighing 12 kg, 38 mL of solution is required for dose/infusion 1, 100 mL for

dose/infusion 2 and 200 mL for dose/infusion 3. Dose 1 is infused at 38 mL/h over 60 mins, dose 2 is

infused at 25 mL/h and dose 3 at 13 mL/h.

4.3

Contraindications

Hypersensitivity to N-acetylcysteine or to any of the excipients listed in section 6.1.

There are no contraindications to the treatment of paracetamol overdose with N-acetylcysteine.

4.4

Special warnings and precautions for use

Management of Paracetamol Overdosage

It should be noted that, after an ingestion of a potentially fatal dose of paracetamol, the patient may

appear relatively well initially and may even continue normal activities for a day or two before the onset

of hepatic failure.

Hepatic damage is more likely to occur with a lower dosage of paracetamol in patients who have a

history

chronic

alcohol

enzyme-inducing

drug

ingestion

(e.g.

isoniazid,

rifampicin,

anticonvulsants including carbamazepine, phenytoin, phenobarbitone, primidone, sodium valproate).

Patients are notoriously unreliable as to the amount ingested and the time of ingestion. Hepatic necrosis

is preventable if treatment can be instituted within 10 to 12 hours of ingestion.

Hepatic necrosis has been seen with 6 grams of paracetamol, and death with 15 grams.

Patient Presenting Within 15 Hours of Ingestion

Give activated charcoal (1 – 2 grams/kg) if it is within 1 hour of paracetamol ingestion, and the patient’s

conscious state is not impaired. In the event of overdose with sustained release paracetamol activated

charcoal may be useful after 1 hour of ingestion.

Plasma paracetamol levels should be obtained no earlier than 4 hours after ingestion of the paracetamol

overdose. Concentrations determined prior to this time are not reliable for assessing potential

hepatotoxicity.

Measurements of plasma liver enzymes and bilirubin levels, and coagulation studies, should be

performed as soon as possible after admission. Blood urea, electrolytes, glucose and blood gases should

be obtained. The laboratory measurement are used to monitor hepatic and renal function and electrolyte

balance. An ECG should also be performed.

Do not delay Acetylcysteine therapy while awaiting the results of plasma assays. Once the results

become available, treatment may be discontinued if the initial concentration is below nomogram

reference line.

Do not discontinue Acetylcysteine therapy if the initial level is above the reference line and subsequent

levels fall below the reference line.

Patients Presenting More Than 15 Hours after Ingestion

NEW ZEALAND DATA SHEET

Page 6 of 10

Plasma paracetamol, bilirubin and AST, ALT levels and INR should be determined urgently. Patients

with INR >1.3 and/or ALT > 150 should be treated. Further advice should be sought from the New

Zealand Poisons Centre.

Anaphylactoid reactions

Anaphylactoid hypersensitivity reactions occur with acetylcysteine, particularly with the initial loading

dose. The patient should be carefully observed during this period for signs of an anaphylactoid reaction.

Nausea, vomiting, flushing, skin rash, pruritus and urticaria are the most common features, but more

serious anaphylactoid reactions have been reported where the patient develops these reactions have

been fatal. There is some evidence that patients with a history of atopy and asthma may be at increased

risk of developing an anaphylactoid reaction.

Most anaphylactoid reactions can be managed by temporally suspending the acetylcysteine infusion,

administering appropriate supportive care, antihistamines and bronchodilators and restarting at a lower

infusion rate. Once an anaphylactoid reaction is under control, the infusion can normally be restarted at

an infusion rate of 50 mg/kg over 4 hours, followed by the final 16 hour infusion (100 mg/kg over 16

hours).

patients

have

previously

experienced

anaphylactoid

reaction

with

acetylcysteine

consideration should be given to pre-treatment with an IV antihistamine 15 minutes before starting the

acetylcysteine infusion.

Coagulation

Changes in haemostatic parameters have been observed in association with acetylcysteine treatment,

some leading to decreased prothrombin time, but most leading to a small increase in prothrombin time

(INR). An isolated increase in prothrombin (INR) time up to 1.3 at the end of a 21 hour course of

acetylcysteine without an elevated transaminase activity does not require further monitoring or

treatment with acetylcysteine.

Fluid and electrolytes

Use with caution in children, patients requiring fluid restriction or those who weigh less than < 40 kg

because of the risk of fluid overload which may result in hyponatraemia and seizures which may be life

threatening (see posology and method of administration for dosing guidelines).

Each 10 mL of N-acetylcysteine for Infusion contains 322.6 mg sodium. To be taken into consideration

with patients on a controlled sodium diet.

Use in Renal/Hepatic Impaired Patients

Caution should be taken when administering Acetylcysteine in patients with hepatic or renal failure,

since there is little data relating to the effects of Acetylcysteine in impaired renal and/or hepatic

function. The decision to administer should be passed on a risk/benefit assessment for the individual

subject.

In the presence of hepatic failure due to paracetamol overdose the degree of existing liver damage and

the possible risk associated with the administration of Acetylcysteine should be considered.

4.5

Interaction with other medicines and other forms of interaction

There are no known interactions.

Effects on Laboratory Tests

Acetylcysteine may cause a false-positive reaction with reagent dipstick tests for urinary ketones.

NEW ZEALAND DATA SHEET

Page 7 of 10

4.6

Fertility, pregnancy and lactation

Pregnancy

Category B2.

There was no evidence of teratogenicity in limited studies in rats and rabbits following administration

of Acetylcysteine during the period of gestation at doses up to 1.2 times the maximum clinical dose, on

a body surface area basis. There are no well-controlled studies in pregnant women but experience does

not include any positive evidence of adverse effects to the foetus.

Use in Lactation

There was no evidence of adverse effects in a limited study in rats following administration of

acetylcysteine during late gestation and lactation at 60% of the maximum clinical dose, on a body

surface area basis. It is not known whether acetylcysteine and/or its metabolites are excreted in milk.

There are no data on the use of acetylcysteine in lactating women and therefore breastfeeding is not

recommended during treatment.

Impairment of Fertility

There was evidence of effects on fertility in male rats given Acetylcysteine at doses up to 60% of the

maximum clinical dose, on a body surface area basis. No effects were observed at doses 15% the

maximum clinical dose, on a body surface area basis.

4.7

Effects on ability to drive and use machines

Acetylcysteine is presumed to be safe since it is unlikely to produce an effect that may impair the

patient's ability to concentrate and react and therefore not constitute a risk in the ability to drive and use

machines.

4.8

Undesirable effects

Intravenous administration of acetylcysteine, especially in the large doses needed to treat paracetamol

overdose, may result in nausea, vomiting and other gastrointestinal symptoms.

Anaphylactoid reactions have been reported following intravenous administration of acetylcysteine.

Bronchospasm may occur in conjunction with a generalized anaphylactic reaction. Other symptoms

include airway obstruction (bronchospasm), angioedema, dyspnoea, hypotension, shock, tachycardia,

urticaria, and injection site reaction (including rash). These reactions occur most commonly either

during, or at the end of the period of the loading dose infusion, and may in fact be dose-related. Since

these anaphylactic-like reactions usually occur following the loading dose, careful monitoring is

recommended.

There have been rare instances of death.

The following adverse effects have been reported:

Blood and lymphatic system disorders

: Thrombocytopenia

Immune system disorders

: Anaphylactoid reaction

Metabolism and nutrition disorders: Acidosis

Psychiatric disorders

: Anxiety

Nervous system disorders:

Syncope, generalized seizure

Eye disorders:

Blurred vision, eye pain

Cardiac disorders:

Cyanosis, tachycardia, bradycardia, cardiac arrest, extrasystoles

Vascular disorders:

Flushing, hypotension, hypertension, vasodilation

Respiratory, thoracic and mediastinal disorders:

Dyspnoea, respiratory arrest, bronchospasm,

coughing, stridor

Gastrointestinal disorders:

Vomiting, nausea

NEW ZEALAND DATA SHEET

Page 8 of 10

Hepatobiliary disorders:

Deterioration of liver function

Skin

and

subcutaneous

tissue

disorders:

Angioedema,

urticaria,

rash

(erythematous

maculopapular), sweating, oedema periorbital

Musculoskeletal and connective tissue disorders:

Arthralgia

General disorders and administration site conditions:

Malaise, rigors, injection site reaction, chest

pain, facial pain, face oedema

Investigations:

Raised temperature, changes in prothrombin time (INR) (usually increased).

Hypokalaemia and ECG changes have been noted in patients with paracetamol poisoning irrespective

of the treatment given. Monitoring of plasma potassium concentration is therefore recommended.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to

report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Symptoms

Symptoms following overdose with acetylcysteine have been similar to those of anaphylactoid reactions

noted under Undesirable Effects (see section 4.8), but they may be more severe. Hypotension appears

to be especially prominent. There is also a theoretical risk of hepatic encephalopathy.

Treatment

There is no specific treatment. General supportive measures should be carried out. It has been suggested

that generalised reactions to acetylcysteine can be treated with intravenous injection of an antihistamine,

and infusion of acetylcysteine should be temporarily stopped but can be restarted at a slower rate

without further reaction.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON

(0800 764766).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Antidotes, ATC Code: V03AB23

Paracetamol is metabolised in the liver, mainly by conjugation with glucuronide and sulphate. It is also

metabolised by cytochrome P450 to form a reactive, potentially toxic metabolite. This metabolite is

normally detoxified by conjugation with hepatic glutathione, to form non-toxic derivatives. In

paracetamol overdosage, the glucuronide and sulphate conjugation pathways are saturated, so that more

of the toxic metabolite is formed. As hepatic glutathione stores are depleted, this toxic metabolite may

bind to hepatocyte proteins, leading to liver cell damage and necrosis. Acetylcysteine is a sulphydryl

(SH) group donor, and may protect the liver from damage by restoring depleted hepatic-reduced

glutathione levels, or by acting as an alternative substrate for conjugation with, and thus detoxification

of, the toxic paracetamol metabolite.

5.2

Pharmacokinetic properties

Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine, and is

deacetylated in the liver to cysteine, or oxidised to other metabolites such as N-acetylcystine or

N,Ndiacetylcystine. The parent compound and metabolites may be present in the plasma either free or

protein bound. Renal clearance accounts for about 30% of total body clearance. Following intravenous

administration, mean terminal half-lives have been calculated to be 1.95 and 5.58 hours respectively for

reduced and total acetylcysteine.

NEW ZEALAND DATA SHEET

Page 9 of 10

5.3

Preclinical safety data

Carcinogenicity assays have not been performed with Acetylcysteine. In rats, no evidence of

carcinogenicity was reported following 18 months of daily dietary administration of Acetylcysteine at

60% of the maximum clinical dose, on a body surface area basis.

No evidence of mutagenicity was obtained in limited gene mutation assays with Acetylcysteine. The

potential for Acetylcysteine to cause chromosomal damage has not been investigated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Disodium Edetate

Nitrogen Gas

Sodium Hydroxide (for pH adjustment where required)

Water for Injection

6.2

Incompatibilities

Acetylcysteine is not compatible with rubber and some metals, particularly, iron, copper and nickel.

Acetylcysteine 200 mg/mL Injection can be used satisfactorily with silicone rubber and plastic.

A change in the colour of the solution to light purple has sometimes been noted and is not thought to

indicate significant impairment of safety or efficacy.

6.3

Shelf life

24 months

Once diluted according to directions (see section 4.2), start using within 3 hours.

6.4

Special precautions for storage

Do not store above 25° C. Keep container in the outer carton.

6.5

Nature and contents of container

10ml Type I clear glass ampoules in packs of 10

6.6

Special precautions for disposal

N-acetylcysteine injection must be diluted prior to administration by intravenous infusion. The

following infusion fluids may be used: 5% dextrose, 0.9% sodium chloride, 0.3% potassium chloride

with 5% glucose, or 0.3% potassium chloride with 0.9% sodium chloride. The volumes to be used are

as directed in Section 4.2.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

7

MEDICINE SCHEDULE

Prescription Medicine.

NEW ZEALAND DATA SHEET

Page 10 of 10

8

SPONSOR

Max Health Ltd

P O Box 65 231

Mairangi Bay

Auckland 0754

Ph:(09) 815 2664

9

DATE OF FIRST APPROVAL

30 October 2008

10

DATE OF REVISION OF THE TEXT

14 July 2017

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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

8-5-2018

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.

FDA - U.S. Food and Drug Administration

8-5-2018

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall: Exposure to particulate matter may result in local irritation/swelling or more serious outcomes.

FDA - U.S. Food and Drug Administration

15-1-2014

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).

Danish Medicines Agency

17-1-2013

Danish Pharmacovigilance Update, 20 December 2012

Danish Pharmacovigilance Update, 20 December 2012

In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.

Danish Medicines Agency

17-10-2012

Danish Pharmacovigilance Update, 20 September 2012

Danish Pharmacovigilance Update, 20 September 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.

Danish Medicines Agency

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

28-3-2018

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Active substance: Chimeric monoclonal antibody against claudin 6) - Transfer of orphan designation - Commission Decision (2018)2009 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/147/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety