| INN |
Indication |
Country of registration |
Concentration |
Current status |
Registration expectation |
| Alfentanil |
Anaesthesia including neuroleptanalgesia by all operations under endotracheal intubation and medical ventilation |
Germany |
5 mg/ml |
Deficiency letter QIII/05 |
QII /06 |
| Thioctic Acid 100 ml RTU |
Paraesthesia by diabetic poly neuropathy |
Germany |
600 mg |
Granted |
|
| Thioctic Acid 250 ml RTU |
Paraesthesia by diabetic poly neuropathy |
Germany |
600 mg |
Granted |
|
| Calcium Folinate |
to diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in adults and children. In cytotoxic therapy, this procedure is commonly known as “Calcium Folinate Rescue |
UK |
10 mg/ml |
Duplicate possible |
Expected QI/06 |
| Clindamycin |
Acute and chronically bacterial infection through Clindamycin sensitive viruses |
Germany |
150 mg/ml |
|
Granted |
| Dexamethasone |
Insufficiency of the adrenal gland, Morbus Addison adrenogenital syndrome, differential diagnosis of Morbus Cushing, severe infectious diseases, autoimmune diseases, chronic aggressive hepatitis, blood diseases, rheumatic diseases, allergic diseases, lymph granulomatosis |
UK |
4 mg/ml; 8 mg/ml, 10 mg/ml |
Deficiency letter QIII/04 |
QI/06 |
| Dobutamine |
Dobutamine is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedure |
Irland |
5mg/ml
12,5 mg/ml
50 mg/ml |
Granted |
|
| Doxorubicin |
Small cell bronchial carcinoma, advanced gastric carcinoma, breast cancer metastasis. |
UK |
2 mg/ml |
Deficiency letter QIII/ 05 |
QIII /06 |
| Flumazenil |
Neutralization of the central depressant acting effect of benzodiazepines |
Niederlande |
0.1 mg/ml |
Granted
Duplicate possible
|
60 days |
| Fluorouracil |
Advanced colorectal carcinoma |
UK |
50 mg/ml |
Duplicate possible |
90 days |
| Glyceryl Trinitrate |
Acute myocardial infarction, acute left heart failure, severe Angina pectoris |
UK |
1 mg/ml |
Granted
Duplicate possible
|
90 days |
| Ketamine |
Initiation and execution of a general anaesthesia |
Ireland |
10 mg/ml
50 mg/ml |
Last deficiency QI/05 |
QI/ 06 |
| Midazolam |
Sedation prior and during diagnostic procedures and therapeutic operations with or without local anaesthesia |
Netherlands |
2 mg/ml |
Granted |
|
| Methotrexate |
Small cell bronchial carcinoma, Chorionepitheliom, acute lymphatic leukaemia malignant in the area of head and neck |
UK |
25 mg/ml
100 mg/ml |
Duplicate possible |
Expected QI/06 |
| Morphin Sulfat |
Analgetic for symptomatic relief of severe pain |
Germany |
1 mg/ml
2 mg/ml
10 mg/ml
15 ml/ml
20 ml/ml |
Granted |
|
| Naloxone |
Postoperative complete or partial reversal of opioid depression, including mild to severe respiratory depression induced by natural and synthetic opioids, except Buprenorphin. |
Netherlands |
0.02 mg/mg
0.4 mg/ml
|
Granted
Duplicate possible
|
90 days |
| Ondansetrone |
Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV). |
Germany |
2 mg/ml |
Granted |
|
| Pamidronic Acid |
Treatment of tumour-induced hypercalcaemia. Prevention of skeletal related events in patients with breast cancer with bone metastases or multiple myeloma with bone lesions grade III. |
Finland |
3 mg/ml |
Duplicate possible |
90 – 180 days |
| Tramadol |
Moderate to strong pain |
Germany |
50 mg/ml |
|
Granted |
